View Clinical Trial (Medical Research Study)
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
| City: |
|
Scranton |
| State: |
|
Pennsylvania |
| Zip Code: |
|
18510 |
| Conditions: |
|
Kidney Injury |
| Purpose: |
|
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in
serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients
following cardiac surgery, and at least 50% of patients with underlying renal insufficiency.
Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk
of developing post-operative AKI. The purpose of the current study is to determine if
intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is
effective at preventing post-operative AKI in patients with baseline kidney insufficiency
and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis
is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic
saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a
preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.
|
| Study Summary: |
|
This is a randomized, placebo-controlled, prospective, double-blinded. The study will take
place at Community Medical Center in Scranton, Pennsylvania. The inclusion criteria are
patients undergoing elective, urgent, or emergent cardiac surgery using cardiopulmonary
bypass and having a baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification
of Diet in Renal Disease equation. Patients will be excluded from the study if they have
cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes
or the need for intra-aortic balloon pump), end-stage kidney disease requiring dialysis,
received an infusion of sodium bicarbonate on the same day as cardiac surgery, or if they
are enrolled in a separate clinical research trial. This trial will involve two treatment
groups. Group one will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively
until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced
to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary
bypass. Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution
using the same infusion regimen as described above for isotonic saline. The primary
efficacy outcome of the study will be the incidence of AKI postoperatively. Acute kidney
injury will be defined as an increase in serum creatinine concentration by at least 25% from
baseline or an absolute increase of 0.5 mg/dL at any time within the first five
postoperative days.
|
| Criteria: |
|
Inclusion Criteria:
- elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
- baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in
Renal Disease equation
Exclusion Criteria:
- cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose
inotropes or the need for intra-aortic balloon pump)
- end-stage kidney disease requiring dialysis
- received an infusion of sodium bicarbonate on the same day as cardiac surgery
|
| NCT ID: |
|
NCT00921518 |
| Primary Contact: |
|
Principal Investigator
Judith L Kristeller, PharmD
Wilkes University
Judith L Kristeller, PharmD
Phone: 570-408-4272
Email: judith.kristeller@wilkes.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Scranton, Pennsylvania 18510
United States
Judith L Kristeller, PharmD
Phone: 570-408-4272
Email: judith.kristeller@wilkes.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|