Trial Outcomes & Findings for Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection (NCT NCT00700375)
NCT ID: NCT00700375
Last Updated: 2010-07-20
Results Overview
The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase \>0.5 mg/dl or \>25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
after procedure and 1,2-3day after procedure
Results posted on
2010-07-20
Participant Flow
Participant milestones
| Measure |
Sodium Bicarbonate Group
Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
Sodium Chloride Group
This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
2 Days After Creatinine Mesurement
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate Group
n=30 Participants
Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
Sodium Chloride Group
n=29 Participants
This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age Continuous
|
76 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
75 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
75 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after procedure and 1,2-3day after procedureThe primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase \>0.5 mg/dl or \>25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.
Outcome measures
| Measure |
Sodium Bicarbonate Group
n=30 Participants
Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
Sodium Chloride Group
n=29 Participants
This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
|---|---|---|
|
Occurrence of Contrast-induced Nephropathy
|
1 participants
|
8 participants
|
Adverse Events
Sodium Bicarbonate Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Chloride Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Bicarbonate Group
n=30 participants at risk
Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
Sodium Chloride Group
n=29 participants at risk
This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
|
|---|---|---|
|
Cardiac disorders
lethal arrhythmia and death
|
6.7%
2/30 • Number of events 2 • 1 month
lethal arrhythmia and death
|
10.3%
3/29 • Number of events 3 • 1 month
lethal arrhythmia and death
|
Other adverse events
Adverse event data not reported
Additional Information
Prevention on Conrast-Induced Nephropathy With Bolus Injection of Sodium Bicarbonate
Osaka General Medical Center
Phone: 81-6-6692-1201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place