Kidney Failure, Acute, Renal Replacement Therapy
Conditions
Keywords
Acute Renal Failure, Cardiac Surgery, Sodium Bicarbonate, Length of Stay, Mortality
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.
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 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.
Interventions
IV bicarbonate given with amount based on patient weight
IV Normal saline with volume given determined by patient weight
IV bicarbonate, dosed by weight
Normal saline, with volume given based on patient weight
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Acute Kidney Injury Within 72 Hours | 72 hours post-operative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GFR Over 72 Hours Post Operatively | 72 hours | 25% or greater change in serum creatinine level |
| Length of Hospital Stay | Until hospital discharge, up to 30 days | Length of hospital stay in days |
| Number of Participants With Need for Dialysis | Until hospital discharge, up to 30 days | Number of participants needing dialysis |
| Mortality | Until hospital discharge, up to 30 days | Number of patients who died during the hospitalization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Sodium Bicarbonate IV sodium bicarbonate given with amount based on patient weight | 64 |
| IV Normal Saline IV Normal saline with volume given determined by patient weight | 59 |
| Total | 123 |
Baseline characteristics
| Characteristic | IV Normal Saline | Total | IV Sodium Bicarbonate |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 13.5 | 70 years STANDARD_DEVIATION 13 | 70.2 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 104 Participants | 57 Participants |
| Region of Enrollment United States | 59 participants | 123 participants | 64 participants |
| Sex: Female, Male Female | 16 Participants | 46 Participants | 30 Participants |
| Sex: Female, Male Male | 43 Participants | 77 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 63 | 10 / 57 |
| other Total, other adverse events | 4 / 63 | 5 / 57 |
| serious Total, serious adverse events | 9 / 63 | 10 / 57 |
Outcome results
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
Time frame: 72 hours post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Sodium Bicarbonate | Number of Participants Who Developed Acute Kidney Injury Within 72 Hours | 17 Participants |
| IV Normal Saline | Number of Participants Who Developed Acute Kidney Injury Within 72 Hours | 14 Participants |
Change in GFR Over 72 Hours Post Operatively
25% or greater change in serum creatinine level
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Sodium Bicarbonate | Change in GFR Over 72 Hours Post Operatively | 21 Participants |
| IV Normal Saline | Change in GFR Over 72 Hours Post Operatively | 21 Participants |
Length of Hospital Stay
Length of hospital stay in days
Time frame: Until hospital discharge, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Sodium Bicarbonate | Length of Hospital Stay | 14.2 days | Standard Deviation 15.4 |
| IV Normal Saline | Length of Hospital Stay | 14.6 days | Standard Deviation 14.4 |
Mortality
Number of patients who died during the hospitalization
Time frame: Until hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Sodium Bicarbonate | Mortality | 9 Participants |
| IV Normal Saline | Mortality | 10 Participants |
Number of Participants With Need for Dialysis
Number of participants needing dialysis
Time frame: Until hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Sodium Bicarbonate | Number of Participants With Need for Dialysis | 4 Participants |
| IV Normal Saline | Number of Participants With Need for Dialysis | 5 Participants |