MedTrace Logo

Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit

NCT02444988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5381

Last updated 2019-12-16

Study results available
· View outcomes & findings →

Summary

The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

Conditions

Interventions

OTHER

0.9% Saline

0.9% Saline will be used whenever an isotonic crystalloid is ordered

OTHER

Physiologically-balanced isotonic crystalloid

Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Todd W Rice, M.D. · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444988 on ClinicalTrials.gov