Phase 2
Completed N=123
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Kidney Failure, Acute · Renal Replacement Therapy
Source: ClinicalTrials.gov NCT00484354 ↗
Enrolled (actual)
123
Serious AEs
15.8%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants Who Developed Acute Kidney Injury Within 72 Hours — 17; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Acute Kidney Injury Within 72 Hours |
17; 14 | — |
| SECONDARY Change in GFR Over 72 Hours Post Operatively |
21; 21 | — |
| SECONDARY Length of Hospital Stay |
14.2; 14.6 | — |
| SECONDARY Number of Participants With Need for Dialysis |
4; 5 | — |
| SECONDARY Mortality |
9; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Calculated GFR ≤ 60 ml/min/m2 (MDRD)
OR
- Any combination of two (2) of the following:
- Age ≥ 70
- Complex surgery (any of the following):
- CABG/Valve
- Redo operation
- Deep hypothermic arrest
- ≥ 2 valves
- History of PVD surgery
- EF < 35%
- Presence of diabetes mellitus
- Prior kidney transplant
Exclusion Criteria
- Age < 18
- Pre-existing ESRD (dialysis patients)
- Pre-op GFR ≤ 15 ml/min/m2
- Pre-op bicarbonate level ≥ 30 mEq/L
- Emergency surgery (unable to effectively consent)
- Pregnancy
- Heart transplant (OHT)
- Aortic surgery (proximal or distal)
Data sourced from ClinicalTrials.gov (NCT00484354). 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. Informational only — not medical advice.