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NCT00484354 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
123
Enrollment target

NCT00484354: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT00484354 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00484354, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
123 participants
Enrollment target

Study 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.

Primary Outcome

Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline

Interventions

  • OTHER Placebo
  • DRUG Sodium bicarbonate
  • OTHER Normal saline
  • OTHER Bicarbonate

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2006-05
Est. Completion 2013-12
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT00484354 record still lists

NCT00484354 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00484354 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00484354 about?

NCT00484354 is a clinical study titled "Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery". 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 50:5...

What is the current status of trial NCT00484354?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2006-05. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00484354?

The interventions under investigation include: Placebo (OTHER), Sodium bicarbonate (DRUG), Normal saline (OTHER), Bicarbonate (OTHER).

Who is sponsoring clinical trial NCT00484354?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00484354's enrollment target sits among peer trials

123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00484354, the US trial registry maintained by the National Library of Medicine. NCT00484354 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.