Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Sodium Bicarbonate for AKI Prevention in Pediatric Cardiac Surgery
NCT02046135Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2013
- Primary completion
- Jun 2017
- Countries
- 1
- Sponsor
- Northwell Health
- Modality
- Small Molecules
- Drugs
- sodium bicarbonate
- Conditions
- acute kidney injury (AKI)
01
Overview
Phase 2, randomised, double-blind trial of sodium bicarbonate in acute kidney injury (AKI) (2 arms), sponsored by Northwell Health. Primary endpoint: Acute Kidney Injury at 7 days. Started Sep 2013; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sodium Bicarbonate
Sodium Bicarbonate infusion (100 meq/L) added to maintenance fluids.
Sodium Chloride
Sodium Chloride (Normal Saline) infusion as placebo.
03
Who it enrols
Children <=18 years scheduled for cardiac surgery with CPB. Excludes those with abnormal creatinine clearance (<90 ml/min/1.7m2), cystic kidney disease, posterior ureteral valves, metabolic disorders, or premature infants <30 weeks gestation and <30 days old.
04
Endpoints
Primary
Acute Kidney Injury
Secondary
Cumulative Fluid Balance
Hospital and Intensive Care Unit Length of Stay
Need for Dialysis
Length of Mechanical Ventilation
Beyond the preview
Go deeper on NCT02046135.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02046135.