Phase 2 N=92 Randomized Triple-blind Prevention

Prevention of Acute Kidney Injury in Cardiac Surgery Patients

Kidney Injury

Bottom Line

View on ClinicalTrials.gov: NCT00921518 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Number of Participants With Acute Kidney Injury — 20; 14 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 0.9% Sodium Chloride (Placebo) (Drug); Sodium Bicarbonate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Community Medical Center, Scranton, PA
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Kidney Injury	20; 14	—

Summary

Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.

Eligibility Criteria

Inclusion Criteria

elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation

Exclusion Criteria

cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
end-stage kidney disease requiring dialysis
received an infusion of sodium bicarbonate on the same day as cardiac surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00921518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.