Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Contrast Induced Nephropathy Clinical Trial

Official title:

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770614
• Other study ID #: Prato0703
• Secondary ID: POCARD0703
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: May 6, 2012
• Start date: March 2004
• Est. completion date: December 2008

Study information

• Verified date: May 2012
• Source: Ospedale Misericordia e Dolce
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria:

• refusal to consent

• previous contrast exposure within 72 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• sodium bicarbonate solution
154 mEq/L in dextrose and H2O
• Isotonic saline
0.9% sodium chloride
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Ospedale Misericordia e Dolce	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration		1 month	Yes