CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
0.9% Normal Saline (0.9% Sodium Chloride) injection +1 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/NCT02668952
NCT02668952Phase 2Completed

The Impact of Low Chloride Containing Fluids on Acute Kidney Injury After Cardiopulmonary Bypass as Assayed by Urinary [TIMP2*IGFBP7]

University of New Mexico·interventional·Posted Jan 29, 2016·Updated May 14, 2018

In Brief

A Phase 2 clinical trial evaluating 0.9% Normal Saline (0.9% Sodium Chloride) injection and Isolyte S injection for Acute Kidney Injury. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models, excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients (up to 40 enrolled) into 2 study arms and compare renal outcomes.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 29, 2016
Enrollment StartJan 1, 2016
Primary CompletionFeb 4, 2017
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.4 years ago

Interventions

0.9% Normal Saline (0.9% Sodium Chloride) injectiondrug

Isolyte S injectiondrug