Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Sodium Bicarbonate vs Saline for CIN Prevention in STEMI
NCT00770614Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2004
- Primary completion
- Jun 2008
- Countries
- 1
- Sponsor
- Ospedale Misericordia e Dolce
- Modality
- Small Molecules
- Drugs
- sodium bicarbonate
- Conditions
- contrast-induced nephropathy (CIN)
01
Overview
Phase 4, randomised, open-label trial of sodium bicarbonate in contrast-induced nephropathy (CIN) (3 arms), sponsored by Ospedale Misericordia e Dolce. Primary endpoint: Absolute or relative increase in serum creatinine concentration at 5 days. Started Mar 2004; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Sodium Bicarbonate
Sodium Bicarbonate 3 mL/kg 1h pre + 1 mL/kg/h 12h post
Isotonic Saline
Isotonic Saline 1 mL/kg/h 12h post
Placebo
Placebo
03
Who it enrols
Patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention, excluding those with previous contrast exposure within 72 hours.
04
Endpoints
Primary
Absolute or relative increase in serum creatinine concentration
Secondary
Adverse clinical events including in-hospital death and need for dialysis
Beyond the preview
Go deeper on NCT00770614.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00770614.