Diabetes mellitus with renal insufficiency MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10038474 Term: Renal insufficiency
Conditions
Interventions
Trade Name: Ardeaelytosol conc. natriumhydrogenkarbonát 4,2% (8,4%)
Product Name: Sodium bicarbonate
Product Code: NaHCO3
Pharmaceutical Form: Solution for infusion
Other descriptive name: SODIUM BICA
Sponsors
Institute for Clinical and Experimental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic
Outcome results
None listed