Can the global end-diastolic volume index guide fluid management in septic patients? A multicenter randomized controlled trial.

Aim: An index that accurately measures intravascular volume is paramount for the optimal resuscitation of sepsis. Selecting an adequate indicator to substitute for central venous pressure (CVP) has remained an issue. The objective of our study was to compare the usefulness of standard early goal-directed therapy (EGDT) with CVP (EGDT-CVP) and modified EGDT with global end-diastolic volume index (GEDI; EGDT-GEDI) for sepsis.
Methods: This was a multicenter prospective randomized controlled study. All patients with sepsis who were expected to require mechanical ventilator support for a minimum of 48 h were included. The patients were classified into an EGDT-CVP group and an EGDT-GEDI group. All participants underwent the extubation protocol. The primary outcome was the ventilator-free days over a 28-day period.
Results: The ventilator-free days was not significantly different between the two groups ( P  = 0.59). However, the EGDT-GEDI group showed a trend of shorter ventilator support duration (5.1 days [2.0-8.7 days] versus 3.9 days [2.4-5.7 days], P  = 0.27) and length of stay in the intensive care unit (7.2 days [3.8-10.7 days] versus 5.1 days [3.7-8.8 days], P  = 0.05) and a smaller 3-day infusion balance than the EGDT-CVP group (4,405 mL [1,092-8,163 mL] versus 3,046 mL [830-6,806 mL], P  = 0.34), but the differences were not statistically significant.
Conclusion: Although there was no significant efficacy, EGDT guided by GEDI showed a trend of shorter length of stay in the intensive care unit and lower 3-day infusion balance than the EGDT-CVP group in sepsis. The GEDI monitoring did not appear to improve the ventilator-free days over a 28-day period.
Competing Interests: Approval of the research protocol: This study was approved by the institutional research committees of all participating institutions. Informed consent: Written informed consent to participate was obtained from the patients, their families, or their legally authorized proxies. Registry and registration no.: The study was registered with the University Medical Information Network Clinical Trial Registry (UMIN‐CTR ID000011493). Animal studies: N/A. Conflict of interest: YT was a member of the medical advisory board of Pulsion Medical Systems. The other authors declare no competing interests.
(© 2019 The Authors. Acute Medicine & Surgery published by John Wiley & Sons Australia, Ltd on behalf of Japanese Association for Acute Medicine.)