IRCT2015011618389N3
Completed
Phase 3
A clinical trial of the comparison of the effect of drug Na/K citrate per os plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast
Qom University of Medical Sciences and Health Services Vice chancellor0 sites400 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute renal failure.
- Sponsor
- Qom University of Medical Sciences and Health Services Vice chancellor
- Enrollment
- 400
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The inclusion criteria are the existence of at least one risk factor of contrast\-induced nephropathy, namely: 1\- Moderate systolic heart failure \[ (EF) Ejection Fraction between 30\-45%]2\- Diabetes mellitus 3\- Older than 75 year\-old 4\- Moderate renal insufficiency (serum creatinine level between 1/5\-2 mg/dl) 5\- Hypotension (systolic blood pressure less than 90 mm Hg 6\- Anaemia 7\- History of hypertension. Exclusion criteria; 1\- pregnancy and lactation 2\- History of allergic reaction to contrast media 3\- Occurrence of cardiogenic shock and pulmonary edema during study 4\-Urgent catheterization 5\- Serum creatinine level higher than 2 mg/dl and previous history of dialysis 6\- Receiving contrast medium 48 h before and after the intervention 7\- Receiving diuretics, N\-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study 8\- Requiring to continue hydration therapy (e.g., sepsis condition) 9\-Severe heart failure \[left ventricular ejection fraction (LVEF) less than 30%]
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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