Balanced Solution Versus Saline in Intensive Care Study
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospital do Coracao
- Enrollment
- 11,075
- Locations
- 1
- Primary Endpoint
- Mortality
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Plasma-Lyte, Slow Infusion
Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.
Intervention: Plasma-Lyte (Drug)
Plasma-Lyte, Slow Infusion
Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.
Intervention: Slow infusion speed (Other)
Plasma-Lyte, Fast Infusion
Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.
Intervention: Plasma-Lyte (Drug)
Plasma-Lyte, Fast Infusion
Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.
Intervention: Fast Infusion Speed (Other)
Saline 0.9%, Slow Infusion
Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.
Intervention: Saline 0.9% (Drug)
Saline 0.9%, Slow Infusion
Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.
Intervention: Slow infusion speed (Other)
Saline 0.9%, Fast Infusion
Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.
Intervention: Saline 0.9% (Drug)
Saline 0.9%, Fast Infusion
Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.
Intervention: Fast Infusion Speed (Other)
Outcomes
Primary Outcomes
Mortality
Time Frame: 90 days
Secondary Outcomes
- Renal Injury (KDIGO equal or greater than 2)(Days 3 and 7)
- Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)(Days 3 and 7)
- Renal failure requiring renal replacement therapy(90 days)
- Mechanical ventilation free days(28 days)