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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bicarbonate administration |
|
| 2 | Placebo Comparator | Normal saline administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | IV bicarbonate given with amount based on patient weight |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GFR Over 72 Hours Post Operatively | 25% or greater change in serum creatinine level | 72 hours |
| Length of Hospital Stay | Length of hospital stay in days |
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Inclusion Criteria:
OR
Any combination of two (2) of the following:
Age ≥ 70
Complex surgery (any of the following):
≥ 2 valves
History of PVD surgery
EF < 35%
Presence of diabetes mellitus
Prior kidney transplant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael V. Rocco, MD | Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Sodium Bicarbonate | IV sodium bicarbonate given with amount based on patient weight |
| FG001 | IV Normal Saline | IV Normal saline with volume given determined by patient weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Sodium Bicarbonate | IV sodium bicarbonate given with amount based on patient weight |
| BG001 | IV Normal Saline | IV Normal saline with volume given determined by patient weight |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 72 hours post-operative |
|
Until hospital discharge, up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Sodium Bicarbonate | IV sodium bicarbonate given with amount based on patient weight |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | General disorders | Systematic Assessment | Mortality |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dialysis | Renal and urinary disorders | Systematic Assessment | Need for dialysis for treatment of acute kidney injury |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Rocco, MD | Wake Forest School of Medicine | 3367164650 | mrocco@wakehealth.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D000077330 | Saline Solution |
| D001639 | Bicarbonates |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
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| Normal saline |
| Other |
IV Normal saline with volume given determined by patient weight |
|
| Bicarbonate | Other | IV bicarbonate, dosed by weight |
|
| Placebo | Other | Normal saline, with volume given based on patient weight |
|
| Until hospital discharge, up to 30 days |
| Number of Participants With Need for Dialysis | Number of participants needing dialysis | Until hospital discharge, up to 30 days |
| Mortality | Number of patients who died during the hospitalization | Until hospital discharge, up to 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in GFR Over 72 Hours Post Operatively | 25% or greater change in serum creatinine level | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay in days | Posted | Mean | Standard Deviation | days | Until hospital discharge, up to 30 days |
|
|
|
| Secondary | Number of Participants With Need for Dialysis | Number of participants needing dialysis | Posted | Count of Participants | Participants | Until hospital discharge, up to 30 days |
|
|
|
| Secondary | Mortality | Number of patients who died during the hospitalization | Posted | Count of Participants | Participants | Until hospital discharge, up to 30 days |
|
|
|
| 9 |
| 63 |
| 9 |
| 63 |
| 4 |
| 63 |
| EG001 | IV Normal Saline | IV Normal saline with volume given determined by patient weight | 10 | 57 | 10 | 57 | 5 | 57 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |