CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Plasmalyte 3ml/kg/hr group +1 moredrug
Likely dose
Plasmalyte 3ml/kg/hr groupfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02135146
NCT02135146Phase 4Completed

Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach

University of Colorado, Denver·interventional·Posted May 9, 2014·Updated Mar 3, 2020

In Brief

A Phase 4 clinical trial evaluating Plasmalyte 3ml/kg/hr group and Plasmalyte 6ml/kg/hr group for Hypotension and Kidney Injury. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 9, 2014
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.1 years ago

Interventions

Plasmalyte 3ml/kg/hr groupdrug

This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them

Plasmalyte 6ml/kg/hr groupdrug

This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them