NCT02875873

Balanced Solution Versus Saline in Intensive Care Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11,075 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.

Conditions

• Critical Illness
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Plasma-Lyte	Plasma-Lyte will be used for fluid expansion and maintenance
DRUG	Saline 0.9%	Saline 0.9% will be used for fluid expansion and maintenance
OTHER	Slow infusion speed	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.
OTHER	Fast Infusion Speed	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.

Timeline

• Start date: 2017-05-27
• Primary completion: 2020-03-02
• Completion: 2021-02-28
• First posted: 2016-08-23
• Last updated: 2021-04-19

Locations

1 site across 1 country: Brazil