Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

NCT ID: NCT00606827

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-03-31

Brief Summary

Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.

Conditions

Contrast-Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

A

Bicarbonate

Group Type: EXPERIMENTAL

Sodium Bicarbonate

Intervention Type: DRUG

Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure

B

Saline

Group Type: ACTIVE_COMPARATOR

Isotonic Saline

Intervention Type: DRUG

Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

Interventions

Sodium Bicarbonate

Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure

Intervention Type: DRUG

Isotonic Saline

Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with creatinine clearance < 60 mL/min

Exclusion Criteria

• contrast medium administration within the previous 10 days
• end-stage renal failure requiring dialysis
• refusal to give informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Misericordia e Dolce

OTHER

Sponsor Role: lead

Responsible Party

Mauro Maioli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro Maioli, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Unit - Prato

Locations

Ospedale Misericordia e Dolce

Prato, Prato, Italy

Countries

Italy

References

Maioli M, Toso A, Leoncini M, Gallopin M, Tedeschi D, Micheletti C, Bellandi F. Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. J Am Coll Cardiol. 2008 Aug 19;52(8):599-604. doi: 10.1016/j.jacc.2008.05.026.

Reference Type: DERIVED

PMID: 18702961 (View on PubMed)

Other Identifiers

POCARD0701

Identifier Type: -

Identifier Source: secondary_id

Prato0701

Identifier Type: -

Identifier Source: org_study_id