Emergent Coronary Procedure
Conditions
Keywords
Patients undergoing an emergent coronary procedure
Brief summary
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
Detailed description
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
Interventions
DRUGSodium bicarbonate
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
DRUGSodium Chloride
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Sponsors
Osaka General Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an emergent coronary procedure(within 60 minutes from admission)
Exclusion criteria
* On dialysis * Pregnancy * Past use of bicarbonate or N-Acetyl-Cystein in 48hr * Past exposure to contrast media in 48hr * Circulatory insufficiency with lactic acidosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Contrast-induced Nephropathy | after procedure and 1,2-3day after procedure | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 29 |
| Total | 59 |
Baseline characteristics
| Characteristic | Sodium Chloride Group | Sodium Bicarbonate Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 26 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 11 Participants |
| Age Continuous | 75 years STANDARD_DEVIATION 10.3 | 76 years STANDARD_DEVIATION 9.3 | 75 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Japan | 29 participants | 30 participants | 59 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 2 / 30 | 3 / 29 |
Outcome results
Primary
Occurrence of Contrast-induced Nephropathy
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.
Time frame: after procedure and 1,2-3day after procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sodium Bicarbonate Group | Occurrence of Contrast-induced Nephropathy | 1 participants |
| Sodium Chloride Group | Occurrence of Contrast-induced Nephropathy | 8 participants |