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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 is a Phase 2 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 51 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046135
The ClinicalTrials.gov registry entry for NCT02046135 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sodium Bicarbonate is the first listed.
NCT02046135 reports 0 study locations.
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.
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