Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484354
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2007-06-06
Brief Title:
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Reduction of Acute Renal Failure Associated With Cardiovascular Surgery A Randomized Study Comparing Sodium Bicarbonate to Normal Saline
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 5050 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
Detailed Description:
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 0150 M NaHCO3 solution prepared in a sterile water base An initial bolus of 0150 M NaHCO3 at 50 mlkg will be given over fifteen minutes prior to surgery Following the bolus the 0150 M NaHCO3 infusion will be run at 10 mlkghr during the procedure and for six 6 hours afterwards The NaHCO3 infusion will then be decreased to 04 mlkghr for a further twelve 12 hours The goal in the NaHCO3 arm is to provide a total dose of approximately 25-30 mEqkg 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 0154 M NaCl NS at 50 mlkg given over fifteen minutes prior to surgery Following the bolus these patients will receive NS 0154 M at a rate of 10 mlkghour during the procedure and for six 6 hours afterwards The rate will then be decreased to 04 mlkghour for a further twelve 12 hours as done in the NaHCO3 treatment arm above There will be a maximum rate of infusion of 125 mLmin 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
I Patients allocated to the sodium bicarbonate NaHCO3 arm will receive a 0150 M NaHCO3 solution prepared in a sterile water base An initial bolus of 0150 M NaHCO3 at 50 mlkg will be given over fifteen minutes prior to surgery Following the bolus the 0150 M NaHCO3 infusion will be run at 10 mlkghr during the procedure and for six 6 hours afterwards The NaHCO3 infusion will then be decreased to 04 mlkghr for a further twelve 12 hours The goal in the NaHCO3 arm is to provide a total dose of approximately 25-30 mEqkg 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 0154 M NaCl NS at 50 mlkg given over fifteen minutes prior to surgery Following the bolus these patients will receive NS 0154 M at a rate of 10 mlkghour during the procedure and for six 6 hours afterwards The rate will then be decreased to 04 mlkghour for a further twelve 12 hours as done in the NaHCO3 treatment arm above There will be a maximum rate of infusion of 125 mLmin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None