Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00484354 |
Recruitment Status
:
Completed
First Posted
: June 8, 2007
Last Update Posted
: November 6, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Failure, Acute Renal Replacement Therapy | Other: Sodium bicarbonate Other: Normal saline Other: Bicarbonate Other: Placebo | Not Applicable |
This is a randomized, controlled, single center study in patients felt to be at high risk for ARF following CABG surgery. Patients who have met the selection criteria noted below will be randomized to one of two treatment arms:
I) Patients allocated to the sodium bicarbonate (NaHCO3) arm will receive a 0.150 M NaHCO3 solution prepared in a sterile water base. An initial bolus of 0.150 M NaHCO3 at 5.0 ml/kg will be given over fifteen minutes prior to surgery. Following the bolus, the 0.150 M NaHCO3 infusion will be run at 1.0 ml/kg/hr during the procedure and for six (6) hours afterwards. The NaHCO3 infusion will then be decreased to 0.4 ml/kg/hr for a further twelve (12) hours. The goal in the NaHCO3 arm is to provide a total dose of approximately 2.5-3.0 mEq/kg of sodium bicarbonate. This dose was determined from prior studies and found to lead to a slight increase in the serum bicarbonate level post-operatively. Anecdotally, the metabolic stress of CABG surgery often leads to a decline in the serum bicarbonate level in patients not treated with alkali therapy.
II) Patients allocated to the normal saline (NS) arm will receive an initial bolus consisting of 0.154 M NaCl (NS) at 5.0 ml/kg given over fifteen minutes prior to surgery. Following the bolus, these patients will receive NS (0.154 M) at a rate of 1.0 ml/kg/hour during the procedure and for six (6) hours afterwards. The rate will then be decreased to 0.4 ml/kg/hour for a further twelve (12) hours as done in the NaHCO3 treatment arm above. There will be a maximum rate of infusion of 125 mL/min used in both study arms to avoid volume overload issues in morbidly obese patients.
There will be no other deviation from standard protocol when treating these patients undergoing CABG at our institution. The standard protocol is dictated by both the cardiothoracic surgeons and anesthesiologists involved with each individual case. The purpose of this study is to compare the incidence of ARF (maximal change in SCr) in high risk patients undergoing CABG when treated with either a NS or NaHCO3 maintenance infusion. This study will test the hypothesis that treatment with NaHCO3 may have a protective effect over NS in preventing AFR following CABG in a high risk population.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Bicarbonate administration
|
Other: Sodium bicarbonate
IV bicarbonate given with amount based on patient weight
Other: Bicarbonate
IV bicarbonate, dosed by weight
|
Placebo Comparator: 2
Normal saline administration
|
Other: Normal saline
IV Normal saline with volume given determined by patient weight
Other: Placebo
Normal saline, with volume given based on patient weight
|
- Maximum change in serum creatinine level (SCr) over the 72 hour post-operative period [ Time Frame: 72 hours post-operative ]
- Maximum change in GFR over 72 hours post operatively [ Time Frame: 2 weeks ]
- Length of hospital stay [ Time Frame: 2 weeks ]
- Incidence of need for dialysis for treatment of acute renal failure [ Time Frame: 2 weeks ]
- Mortality [ Time Frame: 2 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484354
United States, North Carolina | |
Wake Forest University School of Medicine | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Michael V. Rocco, MD | Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT00484354 History of Changes |
Other Study ID Numbers: |
IRB00002409 |
First Posted: | June 8, 2007 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | December 2013 |
Keywords provided by Wake Forest University Health Sciences:
Acute Renal Failure Cardiac Surgery Sodium Bicarbonate Length of Stay Mortality |
Additional relevant MeSH terms:
Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases |