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1. A simplified (modified) Duke Activity Status Index (M-DASI) to characterise functional capacity: A secondary analysis of the Measurement of Exercise Tolerance before Surgery (METS) study

Author

Riedel, B., Li, M.H-G, Lee, C.H.A., Ismail, H., Cuthbertson, B.H., Wijeysundera, D.N., Ho, K.M., Wallace, S., Thompson, B., Ellis, M., Borg, B., Kerridge, R.K., Douglas, J., Brannan, J., Pretto, J., Godsall, M.G., Beauchamp, N., Allen, S., Kennedy, A., Wright, E., Malherbe, J., Melville, A., Sivakumar, H., Murmane, A., Kenchington, K., Kirabiyik, Y., Gurunathan, U., Stonell, C., Brunello, K., Steele, K., Tronstad, O., Masel, P., Dent, A., Smith, E., Bodger, A., Abolfathi, M., Sivalingam, P., Hall, A., Painter, T.W., Macklin, S., Elliott, A., Carrera, A.M., Terblanche, N.C.S., Pitt, S., Samuels, J., Wilde, C., Leslie, K., MacCormick, A., Bramley, D., Southcott, A.M., Grant, J., Taylor, H., Bates, S., Towns, M., Tippett, A., Marshall, F., Mazer, C.D., Kunasingam, J., Yagnik, A., Crescini, C., Yagnik, S., McCartney, C.J.L., Choi, S., Somascanthan, P., Flores, K., Au, S., Beattie, W.S., Karkouti, K., Clarke, H.A., Jerath, A., McCluskey, S.A., Wasowicz, M., Day, L., Pazmino-Canizares, J., Oh, P., Belliard, R., Lee, L., Dobson, K., Chan, V., Brull, R., Ami, N., Stanbrook, M., Hagen, K., Campbell, D., Short, T., Van Der Westhuizen, J., Higgie, J.K., Lindsay, H., Jang, R., Wong, C., Mcallister, D., Ali, M., Kumar, J., Waymouth, E., Kim, C., Dimech, J., Lorimer, M., Tai, J., Miller, R., Sara, R., Collingwood, A., Olliff, S., Gabriel, S., Houston, H., Dalley, P., Hurford, S., Hunt, A., Andrews, L., Navarra, L., Jason-Smith, A., Thompson, H., McMillan, N., Back, G., Lum, M., Martin, D., S James, S., Filipe, H., Pinto, M., Kynaston, S., Phull, M., Beilstein, C., Bodger, P., Everingham, K., Hu, Y., Niebrzegowska, E., Corriea, C., Creary, T., Januszewska, M., Ahmad, T., Whalley, J., Haslop, R., McNeil, J., Brown, A., MacDonald, N., Pakats, M., Greaves, K., Jhanji, S., Raobaikady, R., Black, E., Rooms, M., Lawrence, H., Koutra, M., Pirie, K., Gertsman, M., Jack, S., Celinski, M., Levett, D., Edwards, M., Salmon, K., Bolger, C., Loughney, L., Seaward, L., Collins, H., Tyrell, B., Tantony, N., Golder, K., Ackland, G.L., Stephens, R.C.M., Gallego-Paredes, L., Reyes, A., Gutierrez del Arroyo, A., Raj, A., Lifford, R., Melo, M., Mamdani, M., Hillis, G., Wijeysundera, H.C., Riedel, B., Li, M.H-G, Lee, C.H.A., Ismail, H., Cuthbertson, B.H., Wijeysundera, D.N., Ho, K.M., Wallace, S., Thompson, B., Ellis, M., Borg, B., Kerridge, R.K., Douglas, J., Brannan, J., Pretto, J., Godsall, M.G., Beauchamp, N., Allen, S., Kennedy, A., Wright, E., Malherbe, J., Melville, A., Sivakumar, H., Murmane, A., Kenchington, K., Kirabiyik, Y., Gurunathan, U., Stonell, C., Brunello, K., Steele, K., Tronstad, O., Masel, P., Dent, A., Smith, E., Bodger, A., Abolfathi, M., Sivalingam, P., Hall, A., Painter, T.W., Macklin, S., Elliott, A., Carrera, A.M., Terblanche, N.C.S., Pitt, S., Samuels, J., Wilde, C., Leslie, K., MacCormick, A., Bramley, D., Southcott, A.M., Grant, J., Taylor, H., Bates, S., Towns, M., Tippett, A., Marshall, F., Mazer, C.D., Kunasingam, J., Yagnik, A., Crescini, C., Yagnik, S., McCartney, C.J.L., Choi, S., Somascanthan, P., Flores, K., Au, S., Beattie, W.S., Karkouti, K., Clarke, H.A., Jerath, A., McCluskey, S.A., Wasowicz, M., Day, L., Pazmino-Canizares, J., Oh, P., Belliard, R., Lee, L., Dobson, K., Chan, V., Brull, R., Ami, N., Stanbrook, M., Hagen, K., Campbell, D., Short, T., Van Der Westhuizen, J., Higgie, J.K., Lindsay, H., Jang, R., Wong, C., Mcallister, D., Ali, M., Kumar, J., Waymouth, E., Kim, C., Dimech, J., Lorimer, M., Tai, J., Miller, R., Sara, R., Collingwood, A., Olliff, S., Gabriel, S., Houston, H., Dalley, P., Hurford, S., Hunt, A., Andrews, L., Navarra, L., Jason-Smith, A., Thompson, H., McMillan, N., Back, G., Lum, M., Martin, D., S James, S., Filipe, H., Pinto, M., Kynaston, S., Phull, M., Beilstein, C., Bodger, P., Everingham, K., Hu, Y., Niebrzegowska, E., Corriea, C., Creary, T., Januszewska, M., Ahmad, T., Whalley, J., Haslop, R., McNeil, J., Brown, A., MacDonald, N., Pakats, M., Greaves, K., Jhanji, S., Raobaikady, R., Black, E., Rooms, M., Lawrence, H., Koutra, M., Pirie, K., Gertsman, M., Jack, S., Celinski, M., Levett, D., Edwards, M., Salmon, K., Bolger, C., Loughney, L., Seaward, L., Collins, H., Tyrell, B., Tantony, N., Golder, K., Ackland, G.L., Stephens, R.C.M., Gallego-Paredes, L., Reyes, A., Gutierrez del Arroyo, A., Raj, A., Lifford, R., Melo, M., Mamdani, M., Hillis, G., and Wijeysundera, H.C.

Abstract

Background Accurate assessment of functional capacity, a predictor of postoperative morbidity and mortality, is essential to improving surgical planning and outcomes. We assessed if all 12 items of the Duke Activity Status Index (DASI) were equally important in reflecting exercise capacity. Methods In this secondary cross-sectional analysis of the international, multicentre Measurement of Exercise Tolerance before Surgery (METS) study, we assessed cardiopulmonary exercise testing and DASI data from 1455 participants. Multivariable regression analyses were used to revise the DASI model in predicting an anaerobic threshold (AT) >11 ml kg −1 min −1 and peak oxygen consumption (VO 2 peak) >16 ml kg −1 min −1, cut-points that represent a reduced risk of postoperative complications. Results Five questions were identified to have dominance in predicting AT>11 ml kg −1 min −1 and VO 2 peak>16 ml.kg −1min −1. These items were included in the M-DASI-5Q and retained utility in predicting AT>11 ml.kg −1.min −1 (area under the receiver-operating-characteristic [AUROC]-AT: M-DASI-5Q=0.67 vs original 12-question DASI=0.66) and VO 2 peak (AUROC-VO2 peak: M-DASI-5Q 0.73 vs original 12-question DASI 0.71). Conversely, in a sensitivity analysis we removed one potentially sensitive question related to the ability to have sexual relations, and the ability of the remaining four questions (M-DASI-4Q) to predict an adequate functional threshold remained no worse than the original 12-question DASI model. Adding a dynamic component to the M-DASI-4Q by assessing the chronotropic response to exercise improved its ability to discriminate between those with VO 2 peak>16 ml.kg −1.min −1 and VO 2 peak<16 ml.kg −1.min −1. Conclusions The M-DASI provides a simple screening tool for further preoperative evaluation, including with cardiopulmonary exercise testing, to guide perioperative management.

Published
2020

2. A simplified (modified) Duke Activity Status Index (M-DASI) to characterise functional capacity: A secondary analysis of the Measurement of Exercise Tolerance before Surgery (METS) study

Author

Riedel, B., Li, M.H-G, Lee, C.H.A., Ismail, H., Cuthbertson, B.H., Wijeysundera, D.N., Ho, K.M., Wallace, S., Thompson, B., Ellis, M., Borg, B., Kerridge, R.K., Douglas, J., Brannan, J., Pretto, J., Godsall, M.G., Beauchamp, N., Allen, S., Kennedy, A., Wright, E., Malherbe, J., Melville, A., Sivakumar, H., Murmane, A., Kenchington, K., Kirabiyik, Y., Gurunathan, U., Stonell, C., Brunello, K., Steele, K., Tronstad, O., Masel, P., Dent, A., Smith, E., Bodger, A., Abolfathi, M., Sivalingam, P., Hall, A., Painter, T.W., Macklin, S., Elliott, A., Carrera, A.M., Terblanche, N.C.S., Pitt, S., Samuels, J., Wilde, C., Leslie, K., MacCormick, A., Bramley, D., Southcott, A.M., Grant, J., Taylor, H., Bates, S., Towns, M., Tippett, A., Marshall, F., Mazer, C.D., Kunasingam, J., Yagnik, A., Crescini, C., Yagnik, S., McCartney, C.J.L., Choi, S., Somascanthan, P., Flores, K., Au, S., Beattie, W.S., Karkouti, K., Clarke, H.A., Jerath, A., McCluskey, S.A., Wasowicz, M., Day, L., Pazmino-Canizares, J., Oh, P., Belliard, R., Lee, L., Dobson, K., Chan, V., Brull, R., Ami, N., Stanbrook, M., Hagen, K., Campbell, D., Short, T., Van Der Westhuizen, J., Higgie, J.K., Lindsay, H., Jang, R., Wong, C., Mcallister, D., Ali, M., Kumar, J., Waymouth, E., Kim, C., Dimech, J., Lorimer, M., Tai, J., Miller, R., Sara, R., Collingwood, A., Olliff, S., Gabriel, S., Houston, H., Dalley, P., Hurford, S., Hunt, A., Andrews, L., Navarra, L., Jason-Smith, A., Thompson, H., McMillan, N., Back, G., Lum, M., Martin, D., S James, S., Filipe, H., Pinto, M., Kynaston, S., Phull, M., Beilstein, C., Bodger, P., Everingham, K., Hu, Y., Niebrzegowska, E., Corriea, C., Creary, T., Januszewska, M., Ahmad, T., Whalley, J., Haslop, R., McNeil, J., Brown, A., MacDonald, N., Pakats, M., Greaves, K., Jhanji, S., Raobaikady, R., Black, E., Rooms, M., Lawrence, H., Koutra, M., Pirie, K., Gertsman, M., Jack, S., Celinski, M., Levett, D., Edwards, M., Salmon, K., Bolger, C., Loughney, L., Seaward, L., Collins, H., Tyrell, B., Tantony, N., Golder, K., Ackland, G.L., Stephens, R.C.M., Gallego-Paredes, L., Reyes, A., Gutierrez del Arroyo, A., Raj, A., Lifford, R., Melo, M., Mamdani, M., Hillis, G., Wijeysundera, H.C., Riedel, B., Li, M.H-G, Lee, C.H.A., Ismail, H., Cuthbertson, B.H., Wijeysundera, D.N., Ho, K.M., Wallace, S., Thompson, B., Ellis, M., Borg, B., Kerridge, R.K., Douglas, J., Brannan, J., Pretto, J., Godsall, M.G., Beauchamp, N., Allen, S., Kennedy, A., Wright, E., Malherbe, J., Melville, A., Sivakumar, H., Murmane, A., Kenchington, K., Kirabiyik, Y., Gurunathan, U., Stonell, C., Brunello, K., Steele, K., Tronstad, O., Masel, P., Dent, A., Smith, E., Bodger, A., Abolfathi, M., Sivalingam, P., Hall, A., Painter, T.W., Macklin, S., Elliott, A., Carrera, A.M., Terblanche, N.C.S., Pitt, S., Samuels, J., Wilde, C., Leslie, K., MacCormick, A., Bramley, D., Southcott, A.M., Grant, J., Taylor, H., Bates, S., Towns, M., Tippett, A., Marshall, F., Mazer, C.D., Kunasingam, J., Yagnik, A., Crescini, C., Yagnik, S., McCartney, C.J.L., Choi, S., Somascanthan, P., Flores, K., Au, S., Beattie, W.S., Karkouti, K., Clarke, H.A., Jerath, A., McCluskey, S.A., Wasowicz, M., Day, L., Pazmino-Canizares, J., Oh, P., Belliard, R., Lee, L., Dobson, K., Chan, V., Brull, R., Ami, N., Stanbrook, M., Hagen, K., Campbell, D., Short, T., Van Der Westhuizen, J., Higgie, J.K., Lindsay, H., Jang, R., Wong, C., Mcallister, D., Ali, M., Kumar, J., Waymouth, E., Kim, C., Dimech, J., Lorimer, M., Tai, J., Miller, R., Sara, R., Collingwood, A., Olliff, S., Gabriel, S., Houston, H., Dalley, P., Hurford, S., Hunt, A., Andrews, L., Navarra, L., Jason-Smith, A., Thompson, H., McMillan, N., Back, G., Lum, M., Martin, D., S James, S., Filipe, H., Pinto, M., Kynaston, S., Phull, M., Beilstein, C., Bodger, P., Everingham, K., Hu, Y., Niebrzegowska, E., Corriea, C., Creary, T., Januszewska, M., Ahmad, T., Whalley, J., Haslop, R., McNeil, J., Brown, A., MacDonald, N., Pakats, M., Greaves, K., Jhanji, S., Raobaikady, R., Black, E., Rooms, M., Lawrence, H., Koutra, M., Pirie, K., Gertsman, M., Jack, S., Celinski, M., Levett, D., Edwards, M., Salmon, K., Bolger, C., Loughney, L., Seaward, L., Collins, H., Tyrell, B., Tantony, N., Golder, K., Ackland, G.L., Stephens, R.C.M., Gallego-Paredes, L., Reyes, A., Gutierrez del Arroyo, A., Raj, A., Lifford, R., Melo, M., Mamdani, M., Hillis, G., and Wijeysundera, H.C.

Abstract

Background Accurate assessment of functional capacity, a predictor of postoperative morbidity and mortality, is essential to improving surgical planning and outcomes. We assessed if all 12 items of the Duke Activity Status Index (DASI) were equally important in reflecting exercise capacity. Methods In this secondary cross-sectional analysis of the international, multicentre Measurement of Exercise Tolerance before Surgery (METS) study, we assessed cardiopulmonary exercise testing and DASI data from 1455 participants. Multivariable regression analyses were used to revise the DASI model in predicting an anaerobic threshold (AT) >11 ml kg −1 min −1 and peak oxygen consumption (VO 2 peak) >16 ml kg −1 min −1, cut-points that represent a reduced risk of postoperative complications. Results Five questions were identified to have dominance in predicting AT>11 ml kg −1 min −1 and VO 2 peak>16 ml.kg −1min −1. These items were included in the M-DASI-5Q and retained utility in predicting AT>11 ml.kg −1.min −1 (area under the receiver-operating-characteristic [AUROC]-AT: M-DASI-5Q=0.67 vs original 12-question DASI=0.66) and VO 2 peak (AUROC-VO2 peak: M-DASI-5Q 0.73 vs original 12-question DASI 0.71). Conversely, in a sensitivity analysis we removed one potentially sensitive question related to the ability to have sexual relations, and the ability of the remaining four questions (M-DASI-4Q) to predict an adequate functional threshold remained no worse than the original 12-question DASI model. Adding a dynamic component to the M-DASI-4Q by assessing the chronotropic response to exercise improved its ability to discriminate between those with VO 2 peak>16 ml.kg −1.min −1 and VO 2 peak<16 ml.kg −1.min −1. Conclusions The M-DASI provides a simple screening tool for further preoperative evaluation, including with cardiopulmonary exercise testing, to guide perioperative management.

Published
2020

3. Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies

Author

Bianchi, C, Ackland, GL, Abbott, TEF, Minto, G, Clark, M, Owen, T, Prabhu, P, May, SM, Reynolds, JA, Cuthbertson, BH, Wijesundera, D, Pearse, RM, Myles, PS, Shulman, MA, Wallace, S, Farrington, C, Thompson, B, Ellis, M, Borg, B, Kerridge, RK, Douglas, J, Brannan, J, Pretto, J, Godsall, MG, Beauchamp, N, Allen, S, Kennedy, A, Wright, E, Malherbe, J, Ismail, H, Riedel, B, Melville, A, Sivakumar, H, Murmane, A, Kenchington, K, Kirabiyik, Y, Gurunathan, U, Stonell, C, Brunello, K, Steele, K, Tronstad, O, Masel, P, Dent, A, Smith, E, Bodger, A, Abolfathi, M, Sivalingam, P, Hall, A, Painter, TW, Macklin, S, Elliott, A, Carrera, AM, Terblanche, NCS, Pitt, S, Samuels, J, Wilde, C, Leslie, K, MacCormick, A, Bramley, D, Southcott, AM, Grant, J, Taylor, H, Bates, S, Towns, M, Tippett, A, Marshall, F, Mazer, CD, Kunasingam, J, Yagnik, A, Crescini, C, Yagnik, S, McCartney, CJL, Choi, S, Somascanthan, P, Flores, K, Wijeysundera, DN, Beattie, WS, Karkouti, K, Clarke, HA, Jerath, A, McCluskey, SA, Wasowicz, M, Granton, JT, Day, L, Pazmino-Canizares, J, Oh, P, Belliard, R, Lee, L, Dobson, K, Chan, V, Brull, R, Ami, N, Stanbrook, M, Hagen, K, Campbell, D, Short, T, Van Der Westhuizen, J, Higgie, K, Lindsay, H, Jang, R, Wong, C, Mcallister, D, Ali, M, Kumar, J, Waymouth, E, Kim, C, Dimech, J, Lorimer, M, Tai, J, Miller, R, Sara, R, Collingwood, A, Olliff, S, Gabriel, S, Houston, H, Dalley, P, Hurford, S, Hunt, A, Andrews, L, Navarra, L, Jason-Smith, A, Thompson, H, McMillan, N, Back, G, Croal, BL, Lum, M, Martin, D, James, S, Filipe, H, Pinto, M, Kynaston, S, Phull, M, Beilstein, C, Bodger, P, Everingham, K, Hu, Y, Niebrzegowska, E, Corriea, C, Creary, T, Januszewska, M, Ahmad, T, Whalley, J, Haslop, R, McNeil, J, Brown, A, MacDonald, N, Pakats, M, Greaves, K, Jhanji, S, Raobaikady, R, Black, E, Rooms, M, Lawrence, H, Koutra, M, Pirie, K, Gertsman, M, Jack, S, Celinski, M, Levett, D, Edwards, M, Salmon, K, Bolger, C, Loughney, L, Seaward, L, Collins, H, Tyrell, B, Tantony, N, Golder, K, Stephens, RCM, Gallego-Paredes, L, Reyes, A, del Arroyo, AG, Raj, A, Lifford, R, King, A, Pollak, C, Williams, C, Patrick, A, West, C, Vickers, E, Green, R, Jones, A, Otto, J, Lach, A, Whittle, J, Paredes, LG, Toner, A, Williams, A, Pradhu, P, Hull, D, Montague, L, Bianchi, C, Ackland, GL, Abbott, TEF, Minto, G, Clark, M, Owen, T, Prabhu, P, May, SM, Reynolds, JA, Cuthbertson, BH, Wijesundera, D, Pearse, RM, Myles, PS, Shulman, MA, Wallace, S, Farrington, C, Thompson, B, Ellis, M, Borg, B, Kerridge, RK, Douglas, J, Brannan, J, Pretto, J, Godsall, MG, Beauchamp, N, Allen, S, Kennedy, A, Wright, E, Malherbe, J, Ismail, H, Riedel, B, Melville, A, Sivakumar, H, Murmane, A, Kenchington, K, Kirabiyik, Y, Gurunathan, U, Stonell, C, Brunello, K, Steele, K, Tronstad, O, Masel, P, Dent, A, Smith, E, Bodger, A, Abolfathi, M, Sivalingam, P, Hall, A, Painter, TW, Macklin, S, Elliott, A, Carrera, AM, Terblanche, NCS, Pitt, S, Samuels, J, Wilde, C, Leslie, K, MacCormick, A, Bramley, D, Southcott, AM, Grant, J, Taylor, H, Bates, S, Towns, M, Tippett, A, Marshall, F, Mazer, CD, Kunasingam, J, Yagnik, A, Crescini, C, Yagnik, S, McCartney, CJL, Choi, S, Somascanthan, P, Flores, K, Wijeysundera, DN, Beattie, WS, Karkouti, K, Clarke, HA, Jerath, A, McCluskey, SA, Wasowicz, M, Granton, JT, Day, L, Pazmino-Canizares, J, Oh, P, Belliard, R, Lee, L, Dobson, K, Chan, V, Brull, R, Ami, N, Stanbrook, M, Hagen, K, Campbell, D, Short, T, Van Der Westhuizen, J, Higgie, K, Lindsay, H, Jang, R, Wong, C, Mcallister, D, Ali, M, Kumar, J, Waymouth, E, Kim, C, Dimech, J, Lorimer, M, Tai, J, Miller, R, Sara, R, Collingwood, A, Olliff, S, Gabriel, S, Houston, H, Dalley, P, Hurford, S, Hunt, A, Andrews, L, Navarra, L, Jason-Smith, A, Thompson, H, McMillan, N, Back, G, Croal, BL, Lum, M, Martin, D, James, S, Filipe, H, Pinto, M, Kynaston, S, Phull, M, Beilstein, C, Bodger, P, Everingham, K, Hu, Y, Niebrzegowska, E, Corriea, C, Creary, T, Januszewska, M, Ahmad, T, Whalley, J, Haslop, R, McNeil, J, Brown, A, MacDonald, N, Pakats, M, Greaves, K, Jhanji, S, Raobaikady, R, Black, E, Rooms, M, Lawrence, H, Koutra, M, Pirie, K, Gertsman, M, Jack, S, Celinski, M, Levett, D, Edwards, M, Salmon, K, Bolger, C, Loughney, L, Seaward, L, Collins, H, Tyrell, B, Tantony, N, Golder, K, Stephens, RCM, Gallego-Paredes, L, Reyes, A, del Arroyo, AG, Raj, A, Lifford, R, King, A, Pollak, C, Williams, C, Patrick, A, West, C, Vickers, E, Green, R, Jones, A, Otto, J, Lach, A, Whittle, J, Paredes, LG, Toner, A, Williams, A, Pradhu, P, Hull, D, and Montague, L

Abstract

BACKGROUND: Impaired cardiac vagal function, quantified preoperatively as slower heart rate recovery (HRR) after exercise, is independently associated with perioperative myocardial injury. Parasympathetic (vagal) dysfunction may also promote (extra-cardiac) multi-organ dysfunction, although perioperative data are lacking. Assuming that cardiac vagal activity, and therefore heart rate recovery response, is a marker of brainstem parasympathetic dysfunction, we hypothesized that impaired HRR would be associated with a higher incidence of morbidity after noncardiac surgery. METHODS: In two prospective, blinded, observational cohort studies, we established the definition of impaired vagal function in terms of the HRR threshold that is associated with perioperative myocardial injury (HRR ≤ 12 beats min-1 (bpm), 60 seconds after cessation of cardiopulmonary exercise testing. The primary outcome of this secondary analysis was all-cause morbidity three and five days after surgery, defined using the Post-Operative Morbidity Survey. Secondary outcomes of this analysis were type of morbidity and time to become morbidity-free. Logistic regression and Cox regression tested for the association between HRR and morbidity. Results are presented as odds/hazard ratios [OR or HR; (95% confidence intervals). RESULTS: 882/1941 (45.4%) patients had HRR≤12bpm. All-cause morbidity within 5 days of surgery was more common in 585/822 (71.2%) patients with HRR≤12bpm, compared to 718/1119 (64.2%) patients with HRR>12bpm (OR:1.38 (1.14-1.67); p = 0.001). HRR≤12bpm was associated with more frequent episodes of pulmonary (OR:1.31 (1.05-1.62);p = 0.02)), infective (OR:1.38 (1.10-1.72); p = 0.006), renal (OR:1.91 (1.30-2.79); p = 0.02)), cardiovascular (OR:1.39 (1.15-1.69); p<0.001)), neurological (OR:1.73 (1.11-2.70); p = 0.02)) and pain morbidity (OR:1.38 (1.14-1.68); p = 0.001) within 5 days of surgery. CONCLUSIONS: Multi-organ dysfunction is more common in surgical patients with cardiac vagal dys

Published
2019

4. Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery

Author

Edwards, MR, Forbes, G, MacDonald, N, Berdunov, V, Mihaylova, B, Dias, P, Thomson, A, Grocott, MPW, Mythen, MG, Gillies, MA, Sander, M, Phan, TD, Evered, L, Wijeysundera, DN, McCluskey, SA, Aldecoa, C, Ripolles-Melchor, J, Hofer, CK, Abukhudair, H, Szczeklik, W, Grigoras, I, Hajjar, LA, Kahan, BC, Pearse, RM, Abbott, T, Martin, T, Januszewska, M, Niebrzegowska, E, Bekele, S, Pates, K, Haines, R, Walker, S, Fowler, A, Oliveira, M, Whalley, J, Stephens, T, Amaral, VDS, May, S, Manou, V, Jones, T, Dunkley, S, Pakats, M-L, Griffiths, B, Fernandez, M, Edwards, M, Jonas, M, Bolger, C, Collings, N, Burnish, R, Kelleher, M, Dawson, H, Lang, A, Campbell, R, Rea, N, Clark, S, Blunt, M, Rosbergen, M, Hodgson, R, Wittenberg, M, Filipe, H, Gleeson, Y, Pakou, G, Szakmany, T, Gunter, U, Hodkinson, G, Reay, M, Gidda, R, Allcock, C, Cole, A, Watts, A, Gardner, W, Tindall, M, Anumakonda, V, Agarwal, N, Price, T, Clark, P, Thompson, R, Fowler, S, Gray, K, McGregor, A, Smith, T, Wilson, T, Guha, A, Hodgson, A, McSkeane, A, Barberis, L, Mohamed, M, Prentice, S, Saunders, Z, Ratnam, V, Pawa, N, Sayan, A, Thankachen, M, Svensson, M-L, Raj, A, Ahmad, N, Ivermee, C, Cashman, J, Smee, E, Kanapeckaite, L, Tuong, P, Corcoran, P, Fitzgerald, E, Peyton, P, Buckley, A, Baulch, S, Claxton, G, Harris, S, Sidiropolous, S, de Almeida, JP, Simoes, C, Galas, FRBG, Camara, L, Malbouisson, LMS, Soares, SD, Fernandes, CR, Joaquim, EHG, Stefani, LC, Falcao, LF, Salgado, M, Guimaraes, GN, Gomes, MDA, Lineburger, E, Navarro, L, Salles, LC, Azi, LMTDA, Prado, RG, Benedetti, RH, de Godoy, EP, Bastos, FA, da Silva, RJC, dos Santos, WF, McCluskey, S, Wijeysundera, D, Pazmino-Canizares, J, Parotto, M, Wasowicz, M, Beattie, S, Meineri, M, Clarke, H, Ladha, K, Jerath, A, Ayach, N, Poonawala, H, Sellers, D, Duncan, D, Carroll, J, Hudson, C, van Vlymen, J, Jaeger, M, Shelley, J, Shore, DD, McQuaide, S, Richebe, P, Godin, N, Gobert, Q, Fortier, LP, Verdonck, O, Sato, H, Schricker, T, Codere-Maruyama, T, Lattermann, R, Hatzakorzian, R, Moore, A, Sato, T, Funk, D, Kowalski, S, Girling, L, Monterola, M, Fidler, K, Markmann, M, Schulte, D, Singer, R, Koch, C, Ruhrmann, S, Habig, L, Edinger, F, Schneck, E, Treskatsch, S, Ertmer, M, Trauzeddel, R-F, Weyland, A, Diers, A, Grote, T, Pabel, S, Lipka, A, Nannen, L, Fleischer, A, Wittmann, M, Winkler, A, Neumann, C, Fingerhut, M-L, Ehrentraut, H, Guttenthaler, V, Heringlake, M, Brandt, S, Olsson, S, Schmidt, C, Schemke, S, Murat, L, Abu Khudair, H, Farhoud, E, Ghidan, A, Al Masri, M, Abu Kwiak, S, Abdel-Nabi, H, Ristescu, I, Jitaru, I, Manole, M, Rusu, D, Gata, A, Gonzalez, AP, Alfonso, SM, Perz, LV, Feijoo, JR, Guerra, Y, Herrero, A, Abad-Motos, A, de Pablo, EL, Martinez-Hurtado, E, Abad-Gurumeta, A, Salvachua-Fernandez, R, Nozal-Mateo, B, de Nadal, M, Galan, P, Visauta, EC, Peral, EC, Da Prat, IC, Suarez, SG, Peral, C, Una-Orejon, R, Caldera-Alvarez, MV, Fernandez-Francos, S, Davila, AS, Ortola, CF, Gutierrez, A, Mugarra, A, Romero, E, Soro, M, Gracia, E, Pozo, N, Villafane, AP, Diez, AF, Sanchez, CGM, Buron, FD, Blanco, RP, Duran, MV, Parada, PD, Torres, MB, Rivas, MC, Brage, SM, Castro, AMG, Conde, MJP, Pardal, CB, Ben, MRT, Perez, A, Sancho, JM, Alarcon, MM, Hofer, C, Mariotti, S, Marcolino, I, Winter, A, McGrane, T, Craven, D, Turnbo, T, Mayo, G, Campbell, D, Klintworth, S, Tilley, A, Weinstein, M, Horan, A, Chowdary, R, Carlon, VA, Balasinorwala, T, Yang, G, Edwards, MR, Forbes, G, MacDonald, N, Berdunov, V, Mihaylova, B, Dias, P, Thomson, A, Grocott, MPW, Mythen, MG, Gillies, MA, Sander, M, Phan, TD, Evered, L, Wijeysundera, DN, McCluskey, SA, Aldecoa, C, Ripolles-Melchor, J, Hofer, CK, Abukhudair, H, Szczeklik, W, Grigoras, I, Hajjar, LA, Kahan, BC, Pearse, RM, Abbott, T, Martin, T, Januszewska, M, Niebrzegowska, E, Bekele, S, Pates, K, Haines, R, Walker, S, Fowler, A, Oliveira, M, Whalley, J, Stephens, T, Amaral, VDS, May, S, Manou, V, Jones, T, Dunkley, S, Pakats, M-L, Griffiths, B, Fernandez, M, Edwards, M, Jonas, M, Bolger, C, Collings, N, Burnish, R, Kelleher, M, Dawson, H, Lang, A, Campbell, R, Rea, N, Clark, S, Blunt, M, Rosbergen, M, Hodgson, R, Wittenberg, M, Filipe, H, Gleeson, Y, Pakou, G, Szakmany, T, Gunter, U, Hodkinson, G, Reay, M, Gidda, R, Allcock, C, Cole, A, Watts, A, Gardner, W, Tindall, M, Anumakonda, V, Agarwal, N, Price, T, Clark, P, Thompson, R, Fowler, S, Gray, K, McGregor, A, Smith, T, Wilson, T, Guha, A, Hodgson, A, McSkeane, A, Barberis, L, Mohamed, M, Prentice, S, Saunders, Z, Ratnam, V, Pawa, N, Sayan, A, Thankachen, M, Svensson, M-L, Raj, A, Ahmad, N, Ivermee, C, Cashman, J, Smee, E, Kanapeckaite, L, Tuong, P, Corcoran, P, Fitzgerald, E, Peyton, P, Buckley, A, Baulch, S, Claxton, G, Harris, S, Sidiropolous, S, de Almeida, JP, Simoes, C, Galas, FRBG, Camara, L, Malbouisson, LMS, Soares, SD, Fernandes, CR, Joaquim, EHG, Stefani, LC, Falcao, LF, Salgado, M, Guimaraes, GN, Gomes, MDA, Lineburger, E, Navarro, L, Salles, LC, Azi, LMTDA, Prado, RG, Benedetti, RH, de Godoy, EP, Bastos, FA, da Silva, RJC, dos Santos, WF, McCluskey, S, Wijeysundera, D, Pazmino-Canizares, J, Parotto, M, Wasowicz, M, Beattie, S, Meineri, M, Clarke, H, Ladha, K, Jerath, A, Ayach, N, Poonawala, H, Sellers, D, Duncan, D, Carroll, J, Hudson, C, van Vlymen, J, Jaeger, M, Shelley, J, Shore, DD, McQuaide, S, Richebe, P, Godin, N, Gobert, Q, Fortier, LP, Verdonck, O, Sato, H, Schricker, T, Codere-Maruyama, T, Lattermann, R, Hatzakorzian, R, Moore, A, Sato, T, Funk, D, Kowalski, S, Girling, L, Monterola, M, Fidler, K, Markmann, M, Schulte, D, Singer, R, Koch, C, Ruhrmann, S, Habig, L, Edinger, F, Schneck, E, Treskatsch, S, Ertmer, M, Trauzeddel, R-F, Weyland, A, Diers, A, Grote, T, Pabel, S, Lipka, A, Nannen, L, Fleischer, A, Wittmann, M, Winkler, A, Neumann, C, Fingerhut, M-L, Ehrentraut, H, Guttenthaler, V, Heringlake, M, Brandt, S, Olsson, S, Schmidt, C, Schemke, S, Murat, L, Abu Khudair, H, Farhoud, E, Ghidan, A, Al Masri, M, Abu Kwiak, S, Abdel-Nabi, H, Ristescu, I, Jitaru, I, Manole, M, Rusu, D, Gata, A, Gonzalez, AP, Alfonso, SM, Perz, LV, Feijoo, JR, Guerra, Y, Herrero, A, Abad-Motos, A, de Pablo, EL, Martinez-Hurtado, E, Abad-Gurumeta, A, Salvachua-Fernandez, R, Nozal-Mateo, B, de Nadal, M, Galan, P, Visauta, EC, Peral, EC, Da Prat, IC, Suarez, SG, Peral, C, Una-Orejon, R, Caldera-Alvarez, MV, Fernandez-Francos, S, Davila, AS, Ortola, CF, Gutierrez, A, Mugarra, A, Romero, E, Soro, M, Gracia, E, Pozo, N, Villafane, AP, Diez, AF, Sanchez, CGM, Buron, FD, Blanco, RP, Duran, MV, Parada, PD, Torres, MB, Rivas, MC, Brage, SM, Castro, AMG, Conde, MJP, Pardal, CB, Ben, MRT, Perez, A, Sancho, JM, Alarcon, MM, Hofer, C, Mariotti, S, Marcolino, I, Winter, A, McGrane, T, Craven, D, Turnbo, T, Mayo, G, Campbell, D, Klintworth, S, Tilley, A, Weinstein, M, Horan, A, Chowdary, R, Carlon, VA, Balasinorwala, T, and Yang, G

Abstract

INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.

Published
2019

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