Trial Outcomes & Findings for Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery (NCT NCT00484354)
NCT ID: NCT00484354
Last Updated: 2018-10-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
72 hours post-operative
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
IV Sodium Bicarbonate
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
59
|
|
Overall Study
COMPLETED
|
63
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
IV Sodium Bicarbonate
n=64 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=59 Participants
IV Normal saline with volume given determined by patient weight
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
69.7 years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
70 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
59 participants
n=107 Participants
|
123 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hours post-operativeNumber (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
Outcome measures
| Measure |
IV Sodium Bicarbonate
n=63 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 Participants
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Number of Participants Who Developed Acute Kidney Injury Within 72 Hours
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 72 hours25% or greater change in serum creatinine level
Outcome measures
| Measure |
IV Sodium Bicarbonate
n=63 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 Participants
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Change in GFR Over 72 Hours Post Operatively
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 30 daysLength of hospital stay in days
Outcome measures
| Measure |
IV Sodium Bicarbonate
n=63 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 Participants
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Length of Hospital Stay
|
14.2 days
Standard Deviation 15.4
|
14.6 days
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 30 daysNumber of participants needing dialysis
Outcome measures
| Measure |
IV Sodium Bicarbonate
n=63 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 Participants
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Number of Participants With Need for Dialysis
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, up to 30 daysNumber of patients who died during the hospitalization
Outcome measures
| Measure |
IV Sodium Bicarbonate
n=63 Participants
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 Participants
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Mortality
|
9 Participants
|
10 Participants
|
Adverse Events
IV Sodium Bicarbonate
Serious events: 9 serious events
Other events: 4 other events
Deaths: 9 deaths
IV Normal Saline
Serious events: 10 serious events
Other events: 5 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
IV Sodium Bicarbonate
n=63 participants at risk
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 participants at risk
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
General disorders
Mortality
|
14.3%
9/63 • Number of events 9 • Until hospital discharge, up to 30 days
|
17.5%
10/57 • Number of events 10 • Until hospital discharge, up to 30 days
|
Other adverse events
| Measure |
IV Sodium Bicarbonate
n=63 participants at risk
IV sodium bicarbonate given with amount based on patient weight
|
IV Normal Saline
n=57 participants at risk
IV Normal saline with volume given determined by patient weight
|
|---|---|---|
|
Renal and urinary disorders
Dialysis
|
6.3%
4/63 • Number of events 4 • Until hospital discharge, up to 30 days
|
8.8%
5/57 • Number of events 5 • Until hospital discharge, up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place