CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Sodium bicarbonate +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/NCT00484354
NCT00484354Phase 2Completed

Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline

Wake Forest University Health Sciences·interventional·Posted Jun 8, 2007·Updated Oct 16, 2018

In Brief

A Phase 2 clinical trial evaluating Sodium bicarbonate, Normal saline, and 2 other interventions for Kidney Failure, Acute and Renal Replacement Therapy. Completed, enrolled 123 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2007
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.1 years ago

Interventions

Sodium bicarbonatedrug

IV bicarbonate given with amount based on patient weight

Normal salineother

IV Normal saline with volume given determined by patient weight

Bicarbonateother

IV bicarbonate, dosed by weight

Placeboother

Normal saline, with volume given based on patient weight