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

Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00606827
Enrollment
500
Registered
2008-02-05
Start date
2005-01-31
Completion date
2006-03-31
Last updated
2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-Induced Nephropathy

Keywords

Contrast-induced nephrophaty, Contrast media, Angiography, Coronary percutaneous intervention

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.

Interventions

DRUGSodium 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

DRUGIsotonic 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

Sponsors

Ospedale Misericordia e Dolce
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026