CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11,075 enrolled
Drug / intervention
Plasma-Lyte +3 moredrug
Likely dose
Not stated in 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/NCT02875873
NCT02875873Phase 3Completed
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Balanced Solution Versus Saline in Intensive Care Study

Hospital do Coracao·interventional·Posted Aug 23, 2016·Updated Apr 19, 2021

In Brief

A Phase 3 clinical trial evaluating Plasma-Lyte, Saline 0.9%, and 2 other interventions for Critical Illness and Acute Kidney Injury. Completed, enrolled 11,075 participants across 1 site.

Detailed Summary

A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Illness, Acute Kidney Injury
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 23, 2016
Enrollment StartMay 27, 2017
Primary CompletionMar 2, 2020
Study CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.9 years ago

Interventions

Plasma-Lytedrug

Plasma-Lyte will be used for fluid expansion and maintenance

Saline 0.9%drug

Saline 0.9% will be used for fluid expansion and maintenance

Slow infusion speedother

Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded.

Fast Infusion Speedother

Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded.