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NCT02046135 · ClinicalTrials.gov registry record · Phase 2
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
A Phase 2 study, sponsored by Northwell Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT02046135: Clinical Trial Phase 2 study, sponsored by Northwell Health.
NCT02046135 is a Phase 2 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02046135, a Phase 2 study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows: 1\. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
Primary Outcome
The number of patients who developed AKI in each arm of the study. AKI was measured by the Pediatric Risk, Failure, Loss of Function, and End-Stage Renal Disease (pRIFLE) criteria or an absolute increase in creatinine of 0.3mg/dl.
Interventions
- DRUG Sodium Bicarbonate
- DRUG Sodium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-07-22 |
| Phase | Phase 2 |
Why NCT02046135 stopped before completion
NCT02046135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Sodium Bicarbonate is the first listed.
NCT02046135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02046135 about?
NCT02046135 is a clinical study titled "Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery". The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bic...
What is the current status of trial NCT02046135?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2013-09. Estimated completion is 2017-07-22.
What interventions are being tested in trial NCT02046135?
The interventions under investigation include: Sodium Bicarbonate (DRUG), Sodium Chloride (DRUG).
Who is sponsoring clinical trial NCT02046135?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02046135's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 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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