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2. Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients

Author

Bellomo, R, Cass, A, Norton, R, Gallagher, M, Lo, S, Su, S, Cole, L, Finfer, S, McArthur, C, McGuinness, S, Myburgh, J, Scheinkestel, C, Lee, J, Ali, D, Goldsmith, D, Banerjee, A, Bhonagiri, D, Blythe, D, Botha, J, Cade, J, Dobb, G, Eddington, J, Flabouris, A, French, C, Garrett, P, Henderson, S, Ihle, B, Joyce, C, Kalkoff, M, Lipman, J, Milliss, D, Mitchell, I, Morgan, J, Nair, P, Orford, N, Raza, A, Shehabi, Y, Tobin, A, Totaro, R, Turner, A, Wright, C, Little, L, Morrison, A, Regaglia, G, Shukla, R, Baigent, C, Emberson, J, Wheeler, D, Young, D, Billot, L, Bompoint, S, Heritier, S, Lo, SN, Pillai, A, Pandey, S, Ryan, S, Schmidt, M, Starzec, G, Vijayan, B, Ashley, R, Gissane, J, Malchukova, K, Ranse, J, Nand, K, Sara, T, Cheung, W, Fugaccia, E, Lawrence, P, Millis, D, Tan, J, Thankrishnan, G, Wong, H, Harrigan, P, Crowfoot, E, Hardie, M, Micallef, S, Brieva, J, Lintott, M, Seppelt, I, Gresham, R, Nikas, M, Weisbrodt, L, Bass, F, Boyle, M, Campbell, M, Hammond, N, Ankers, S, O'Connor, A, Potter, J, Rajbhandari, D, Dhiacou, V, Jovanovska, A, Munster, F, Breeding, J, Burns, C, Morrison, M, Pfeffercorn, C, Ritchie, A, Buhr, H, Eccleston, M, Parke, R, Bell, J, Newby, L, Mehrtens, J, West, C, Rudder, L, Sutton, J, Groves, N, McDonald, S, Jaspers, J, Harwood, M, Helyar, J, Mackie, B, Boots, R, Bertenshaw, C, Deans, R, Fourie, C, Lassig-Smith, M, Stuart, J, Edwards, J, O'Connor, S, Lewis, K, Rivett, J, Field, T, McAllister, R, Marsden, K, Mathlin, C, Mercer, I, O'Sullivan, K, Edington, J, Boschert, C, Smith, J, Graan, M, Ho, S, Fowler, N, McInness, J, Pratt, N, Elderkin, T, Fraser, M, Kinmonth, A, Barrett, J, Wilson, S, Galt, P, Burton, S, Culhane, C, Ioannidis, R, Roberston, M, Barge, D, Caf, T, Howe, B, Low, P, Holmes, J, Smith, R, Davies, A, Murray, L, Nevill, R, Vallance, S, Varley, S, White, V, Raunow, H, Palermo, A, Boardman, M, Chamberlain, J, Gould, A, McEntaggart, G, Perryman, S, Thomas, L, and In, RENALRTS

Subjects
Male, medicine.medical_specialty, Randomization, Critical Illness, medicine.medical_treatment, Hemodiafiltration, Kaplan-Meier Estimate, law.invention, Randomized controlled trial, law, Internal medicine, medicine, Humans, Prospective Studies, Renal replacement therapy, Prospective cohort study, Aged, business.industry, Acute kidney injury, General Medicine, Odds ratio, Acute Kidney Injury, Middle Aged, medicine.disease, Confidence interval, Surgery, Treatment Outcome, Female, business, Hypophosphatemia
Abstract

Background The optimal intensity of continuous renal-replacement therapy remains unclear. We conducted a multicenter, randomized trial to compare the effect of this therapy, delivered at two different levels of intensity, on 90-day mortality among critically ill patients with acute kidney injury. Methods We randomly assigned critically ill adults with acute kidney injury to continuous renal-replacement therapy in the form of postdilution continuous venovenous hemodiafiltration with an effluent flow of either 40 ml per kilogram of body weight per hour (higher intensity) or 25 ml per kilogram per hour (lower intensity). The primary outcome measure was death within 90 days after randomization. Results Of the 1508 enrolled patients, 747 were randomly assigned to higher-intensity therapy, and 761 to lower-intensity therapy with continuous venovenous hemodiafiltration. Data on primary outcomes were available for 1464 patients (97.1%): 721 in the higher-intensity group and 743 in the lower-intensity group. The two study groups had similar baseline characteristics and received the study treatment for an average of 6.3 and 5.9 days, respectively (P = 0.35). At 90 days after randomization, 322 deaths had occurred in the higher-intensity group and 332 deaths in the lower-intensity group, for a mortality of 44.7% in each group (odds ratio, 1.00; 95% confidence interval [CI], 0.81 to 1.23; P = 0.99). At 90 days, 6.8% of survivors in the higher-intensity group (27 of 399), as compared with 4.4% of survivors in the lower-intensity group (18 of 411), were still receiving renal-replacement therapy (odds ratio, 1.59; 95% CI, 0.86 to 2.92; P = 0.14). Hypophosphatemia was more common in the higher-intensity group than in the lower-intensity group (65% vs. 54%, P Conclusions In critically ill patients with acute kidney injury, treatment with higher-intensity continuous renal-replacement therapy did not reduce mortality at 90 days. (ClinicalTrials.gov number, NCT00221013.)

Published
2016

3. Calorie intake and patient outcomes in severe acute kidney injury: Findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial.

Author

Nair P., Kalkoff M., West C., Morgan J., Rudder L., Sutton J., Garrett P., Groves N., McDonald S., Jennifer Palmer a., Joyce C., Harwood M., Helyar J., Mackie B., Lipman J., Boots R., Bertenshaw C., Deans R., Fourie C., Lassig-Smith M., Flabouris A., Edwards J., O'Connor S., Rivett J., Turner A., Field T., Marsden K., Mathlin C., Goldsmith D., Mercer I., O'Sullivan K., Edington J., Boschert C., Smith J., Ihle B., Graan M., Ho S., Botha J., Fowler N., McInness J., Pratt N., Orford N., Elderkin T., Fraser M., Kinmonth A., Wright C., Burton S., Culhane C., Galt P., Rutzou R., Roberston M., Barge D., Caf T., Howe B., Low P., Tobin A., Holmes J., Smith R., Murray L., Nevill R., Vallance S., Varley S., White V., French C., Little L., Raunow H., Blythe D., Palermo A., Dobb G., Boardman M., Chamberlain J., Gould A., McEntaggart G., Perryman S., Thomas L., Bellomo R., Cass A., Cole L., Finfer S., Gallagher M., Lee J., Lo S., McArthur C., McGuinness S., Myburgh J., Norton R., Scheinkestel C., Mitchell I., Ashley R., Gissane J., Malchukova K., Ranse J., Raza A., Nand K., Sara T., Millis D., Tan J., Wong H., Harrigan P., Crowfoot E., Hardie M., Bhonagiri D., Micallef S., Brieva J., Lintott M., Gresham R., Nikas M., Weisbrodt L., Shehabi Y., Bass F., Campbell M., Stockdale V., Ankers S., O'Connor A., Potter J., Totaro R., Rajbhandari D., Dhiacou V., Jovanovska A., Munster F., Davies A., Breeding J., Burns C., Banerjee A., Morrison M., Pfeffercorn C., Ritchie A., Buhr H., Eccleston M., Parke R., Bell J., Newby L., Henderson S., Mehrtens J., Nair P., Kalkoff M., West C., Morgan J., Rudder L., Sutton J., Garrett P., Groves N., McDonald S., Jennifer Palmer a., Joyce C., Harwood M., Helyar J., Mackie B., Lipman J., Boots R., Bertenshaw C., Deans R., Fourie C., Lassig-Smith M., Flabouris A., Edwards J., O'Connor S., Rivett J., Turner A., Field T., Marsden K., Mathlin C., Goldsmith D., Mercer I., O'Sullivan K., Edington J., Boschert C., Smith J., Ihle B., Graan M., Ho S., Botha J., Fowler N., McInness J., Pratt N., Orford N., Elderkin T., Fraser M., Kinmonth A., Wright C., Burton S., Culhane C., Galt P., Rutzou R., Roberston M., Barge D., Caf T., Howe B., Low P., Tobin A., Holmes J., Smith R., Murray L., Nevill R., Vallance S., Varley S., White V., French C., Little L., Raunow H., Blythe D., Palermo A., Dobb G., Boardman M., Chamberlain J., Gould A., McEntaggart G., Perryman S., Thomas L., Bellomo R., Cass A., Cole L., Finfer S., Gallagher M., Lee J., Lo S., McArthur C., McGuinness S., Myburgh J., Norton R., Scheinkestel C., Mitchell I., Ashley R., Gissane J., Malchukova K., Ranse J., Raza A., Nand K., Sara T., Millis D., Tan J., Wong H., Harrigan P., Crowfoot E., Hardie M., Bhonagiri D., Micallef S., Brieva J., Lintott M., Gresham R., Nikas M., Weisbrodt L., Shehabi Y., Bass F., Campbell M., Stockdale V., Ankers S., O'Connor A., Potter J., Totaro R., Rajbhandari D., Dhiacou V., Jovanovska A., Munster F., Davies A., Breeding J., Burns C., Banerjee A., Morrison M., Pfeffercorn C., Ritchie A., Buhr H., Eccleston M., Parke R., Bell J., Newby L., Henderson S., and Mehrtens J.

Abstract

Introduction: Current practice in the delivery of caloric intake (DCI) in patients with severe acute kidney injury (AKI) receiving renal replacement therapy (RRT) is unknown. We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study and to assess the association between DCI and clinical outcomes. Method(s): We performed a secondary analysis in 1456 patients from the RENAL trial. We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression, Cox proportional hazards models, and time adjusted models. Result(s): Overall, mean DCI during treatment in ICU was low at only 10.9 +/- 9 Kcal/kg/day for non-survivors and 11 +/- 9 Kcal/kg/day for survivors. Among patients with a lower DCI (below the median) 334 of 729 (45.8%) had died at 90-days after randomization compared with 316 of 727 (43.3%) patients with a higher DCI (above the median) (P = 0.34). On multivariable logistic regression analysis, mean DCI carried an odds ratio of 0.95 (95% confidence interval (CI): 0.91-1.00; P = 0.06) per 100 Kcal increase for 90-day mortality. DCI was not associated with significant differences in renal replacement (RRT) free days, mechanical ventilation free days, ICU free days and hospital free days. These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling. Conclusion(s): In the RENAL study, mean DCI was low. Within the limits of such low caloric intake, greater DCI was not associated with improved clinical outcomes. © 2014 Bellomo et al.; licensee BioMed Central Ltd.

Published
2014

4. Calorie intake and patient outcomes in severe acute kidney injury: Findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial

Author

Bellomo, R, Cass, A, Cole, L, Finfer, S, Gallagher, M, Lee, J, Lo, S, McArthur, C, McGuinness, S, Myburgh, J, Norton, R, Scheinkestel, C, Mitchell, I, Ashley, R, Gissane, J, Malchukova, K, Ranse, J, Raza, A, Nand, K, Sara, T, Millis, D, Tan, J, Wong, H, Harrigan, P, Crowfoot, E, Hardie, M, Bhonagiri, D, Micallef, S, Brieva, J, Lintott, M, Gresham, R, Nikas, M, Weisbrodt, L, Shehabi, Y, Bass, F, Campbell, M, Stockdale, V, Ankers, S, O'Connor, A, Potter, J, Totaro, R, Rajbhandari, D, Dhiacou, V, Jovanovska, A, Munster, F, Nair, P, Breeding, J, Burns, C, Banerjee, A, Morrison, M, Pfeffercorn, C, Ritchie, A, Buhr, H, Eccleston, M, Parke, R, Bell, J, Newby, L, Henderson, S, Mehrtens, J, Kalkoff, M, West, C, Morgan, J, Rudder, L, Sutton, J, Garrett, P, Groves, N, McDonald, S, Jennifer Palmer, A, Joyce, C, Harwood, M, Helyar, J, Mackie, B, Lipman, J, Boots, R, Bertenshaw, C, Deans, R, Fourie, C, Lassig-Smith, M, Flabouris, A, Edwards, J, O'Connor, S, Rivett, J, Turner, A, Field, T, Marsden, K, Mathlin, C, Goldsmith, D, Mercer, I, O'Sullivan, K, Edington, J, Boschert, C, Smith, J, Ihle, B, Graan, M, Ho, S, Botha, J, Fowler, N, McInness, J, Pratt, N, Orford, N, Bellomo, R, Cass, A, Cole, L, Finfer, S, Gallagher, M, Lee, J, Lo, S, McArthur, C, McGuinness, S, Myburgh, J, Norton, R, Scheinkestel, C, Mitchell, I, Ashley, R, Gissane, J, Malchukova, K, Ranse, J, Raza, A, Nand, K, Sara, T, Millis, D, Tan, J, Wong, H, Harrigan, P, Crowfoot, E, Hardie, M, Bhonagiri, D, Micallef, S, Brieva, J, Lintott, M, Gresham, R, Nikas, M, Weisbrodt, L, Shehabi, Y, Bass, F, Campbell, M, Stockdale, V, Ankers, S, O'Connor, A, Potter, J, Totaro, R, Rajbhandari, D, Dhiacou, V, Jovanovska, A, Munster, F, Nair, P, Breeding, J, Burns, C, Banerjee, A, Morrison, M, Pfeffercorn, C, Ritchie, A, Buhr, H, Eccleston, M, Parke, R, Bell, J, Newby, L, Henderson, S, Mehrtens, J, Kalkoff, M, West, C, Morgan, J, Rudder, L, Sutton, J, Garrett, P, Groves, N, McDonald, S, Jennifer Palmer, A, Joyce, C, Harwood, M, Helyar, J, Mackie, B, Lipman, J, Boots, R, Bertenshaw, C, Deans, R, Fourie, C, Lassig-Smith, M, Flabouris, A, Edwards, J, O'Connor, S, Rivett, J, Turner, A, Field, T, Marsden, K, Mathlin, C, Goldsmith, D, Mercer, I, O'Sullivan, K, Edington, J, Boschert, C, Smith, J, Ihle, B, Graan, M, Ho, S, Botha, J, Fowler, N, McInness, J, Pratt, N, and Orford, N

Abstract

Introduction: Current practice in the delivery of caloric intake (DCI) in patients with severe acute kidney injury (AKI) receiving renal replacement therapy (RRT) is unknown. We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study and to assess the association between DCI and clinical outcomes.Methods: We performed a secondary analysis in 1456 patients from the RENAL trial. We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression, Cox proportional hazards models, and time adjusted models.Results: Overall, mean DCI during treatment in ICU was low at only 10.9 ± 9 Kcal/kg/day for non-survivors and 11 ± 9 Kcal/kg/day for survivors. Among patients with a lower DCI (below the median) 334 of 729 (45.8%) had died at 90-days after randomization compared with 316 of 727 (43.3%) patients with a higher DCI (above the median) (P = 0.34). On multivariable logistic regression analysis, mean DCI carried an odds ratio of 0.95 (95% confidence interval (CI): 0.91-1.00; P = 0.06) per 100 Kcal increase for 90-day mortality. DCI was not associated with significant differences in renal replacement (RRT) free days, mechanical ventilation free days, ICU free days and hospital free days. These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling.Conclusions: In the RENAL study, mean DCI was low. Within the limits of such low caloric intake, greater DCI was not associated with improved clinical outcomes. © 2014 Bellomo et al.; licensee BioMed Central Ltd.

Published
2014

5. A phase II randomised controlled trial of intensive insulin therapy in general intensive care patients.

Author

Mitchell I, Knight E, Gissane J, Tamhane R, Kolli R, Leditschke IA, Bellomo R, and Finfer S

Subjects
Aged, Clinical Trials, Phase I as Topic, Critical Care, Critical Illness mortality, Drug Administration Schedule, Energy Intake, Female, Humans, Hypoglycemia etiology, Male, Middle Aged, Treatment Outcome, Blood Glucose analysis, Critical Illness therapy, Insulin administration & dosage
Abstract

Objective: To determine the safety and efficacy of an intensive insulin regimen compared with a conventional insulin regimen in general intensive care unit patients., Methods: A phase II, randomised controlled trial was conducted in 70 critically ill patients in a closed multidisciplinary ICU of a university-affiliated tertiary hospital. We assessed patient characteristics at baseline. Trial process measures included number of blood glucose measurements per day and number in target range, type and quantity of caloric intake, patient outcome and insulin dosing. The primary outcome was the median blood glucose concentration. Secondary outcome measures were incidence of hypoglycaemia (blood glucose level < 2.2 mmol/L), clinical sequelae of hypoglycaemia and hospital mortality., Results: Thirty-five patients were randomised to each of the two groups. More blood glucose samples were taken per day in the intensive insulin group (16 versus 9), but the number of samples in the normoglycaemic range was 48.5%, compared with 79.8% within the target glucose range in the conventional insulin group. The median (interquartile range) blood glucose concentrations in the intensive and conventional insulin therapy groups were 5.4 (5.1-5.7) mmol/L and 7.9 (7.2-9.0) mmol/L, respectively (difference, 2.5 mmol/L; P < 0.0001). Five patients (14.3%) in the intensive insulin therapy group became hypoglycaemic versus none in the conventional insulin therapy group. There were no detected clinical sequelae of hypoglycaemia., Conclusion: The intensive insulin regimen was effective in achieving the target blood glucose concentration, with clear separation from the conventional insulin regimen. Although the incidence of hypoglycaemia was increased, there was no detectable harm.

Published
2006

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