Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| POCARD0703 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure |
|
| 2 | Active Comparator | Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate solution | Drug | 154 mEq/L in dextrose and H2O |
| |
| Isotonic saline |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration | within 5 days after contrast exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mauro Maioli, MD | Ospedale Misericordia e Dolce, Prato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Misericordia e Dolce | Prato | Prato | 59100 | Italy |
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
0.9% sodium chloride |
|
| Placebo | Drug | Placebo |
|
| D017670 |
| Sodium Compounds |