Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery

NCT00484354 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00002409
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Failure, Acute; Renal Replacement Therapy

Keywords

Acute Renal Failure; Cardiac Surgery; Sodium Bicarbonate; Length of Stay; Mortality

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Acute Kidney Injury Within 72 Hours

  Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline

  72 hours post-operative

Secondary Outcomes (4)

• Change in GFR Over 72 Hours Post Operatively

  72 hours

• Length of Hospital Stay

  Until hospital discharge, up to 30 days

• Number of Participants With Need for Dialysis

  Until hospital discharge, up to 30 days

• Mortality

  Until hospital discharge, up to 30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Bicarbonate administration

Drug: Sodium bicarbonate; Other: Bicarbonate

2

PLACEBO COMPARATOR

Normal saline administration

Other: Normal saline; Other: Placebo

Interventions

Sodium bicarbonate DRUG

IV bicarbonate given with amount based on patient weight

1

Normal saline OTHER

IV Normal saline with volume given determined by patient weight

2

Bicarbonate OTHER

IV bicarbonate, dosed by weight

1

Placebo OTHER

Normal saline, with volume given based on patient weight

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Calculated GFR ≤ 60 ml/min/m2 (MDRD)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate; Saline Solution; Bicarbonates

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Michael Rocco, MD
• Organization: Wake Forest School of Medicine

mrocco@wakehealth.edu

3367164650

Study Officials

• Michael V. Rocco, MD

  Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Locations

US (1)