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Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery

NCT00484354 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2018-10-16

Study results available
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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.

Conditions

  • Kidney Failure, Acute
  • Renal Replacement Therapy

Interventions

DRUG

Sodium bicarbonate

IV bicarbonate given with amount based on patient weight

OTHER

Normal saline

IV Normal saline with volume given determined by patient weight

OTHER

Bicarbonate

IV bicarbonate, dosed by weight

OTHER

Placebo

Normal saline, with volume given based on patient weight

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael V. Rocco, MD · Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-12-31
Completion
2013-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00484354 on ClinicalTrials.gov