CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
Pulse pressure variation monitoringother
Likely dose
Not stated in record
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Search/NCT03128190
NCT03128190N/ACompleted

A Pragmatic Multi-center Trial of Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring During High-risk Surgery

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo·interventional·Posted Apr 25, 2017·Updated Apr 25, 2017

In Brief

A clinical study evaluating Pulse pressure variation monitoring for Goal-directed Fluid Therapy and 4 related conditions. Completed, enrolled 256 participants.

Detailed Summary

Background: Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this hypothesis in a multi-center study. Methods: The patients were included in two periods: a first control period (control group; n=147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV\< 10% in 109 surgical patients (PPV group). It was performed 1:1 propensity score matching to ensure the groups were comparable with regard to age, weight, duration of surgery, and type of operation. The primary endpoint was postoperative hospital length of stay.

Study Details

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2017
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2010
Study CompletionJun 30, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 9.2 years ago

Interventions

Pulse pressure variation monitoringother

fluids boluses of colloids were given to maintain continuously measured PPV at 10% or less