Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy in Diabetic Patients with Renal Insufficiency

• Conditions: Diabetes mellitus with renal insufficiency; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency

• Registration Number: EUCTR2007-007546-36-CZ
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-24
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Scheduled procedure with exposure to radiographic contrast
Age = 18 years
Diabetes mellitus defined by use of antidiabetic medication
Stable renal insufficiency with P-creatinine = 100 µmol/l
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Emergency procedure
P-creatinine = 500 µmol/l or dialysis treatment
Acute renal failure with P-creatinine change of = 50 µmol/l / 24 hours
Fluid overload with pulmonary edema
Uncontrolled hypertension (systolic BP = 180 and/or diastolic BP = 110 mmHg) or hemodynamic instability (systolic BP = 90 and/or diastolic BP = 50 mmHg)
Allergy to or use of radiographic contrast within 2 days of the study
Use of other treatment to prevent contrast-induced nephropathy
Multiple myeloma
Pregnancy
Planned use of other medical substance to prevent radiocontrast nephropathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of sodium bicarbonate versus sodium chloride infusion for the prevention of contrast-induced nephropathy (defined as maximum change in plasma creatinine = 25%, or = 44,2 µmol/l on postcontrast days 1 and 2) in diabetic patients with renal insufficiency undergoing procedures with exposure to radiographic contrast ;Secondary Objective: To asess the effect of sodium bicarbonate versus sodium chloride infusion on the maximum change in plasma creatinine and estimated glomerular filtration rate (MDRD equation) in diabetic patients with renal insufficiency undergoing procedures with exposure to radiographic contrast ;Primary end point(s): Maximal change in P-creatinine within postcontrast days 1 and 2 versus precontrast level