Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Hospital Sao Lucas da PUCRS

Status and phase: Completed; Phase 3

Conditions: Renal Failure

Treatments: Drug: sodium bicarbonate; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01172353

HSaoLucas

Details and patient eligibility

About

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• serum creatinine > 1.1 mg/dL
• glomerular filtration rate (GFR) < 50 mL/min

Exclusion criteria

• age < 18 years
• use of radiographic contrast media during the last 21 days
• history of dialysis
• cardiac insufficiency class III-IV
• emergency procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

301 participants in 2 patient groups

sodium bicarbonate

Experimental group

Description:

hydration with sodium bicarbonate

Treatment:

Drug: sodium bicarbonate

saline

Active Comparator group

Description:

hydration with saline 1ml/Kg/h for 6 hours

Treatment:

Drug: saline