Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.

Detailed Description
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Contrast nephropathy may occur after using intravenous contrast media and may result in acute renal failure. Contrast nephropathy usually reversible but in some cases it can be permanent. This situation increase the time of hospitalization and mortality of the patients. Although the only proved prevention from contrast nephropathy method is hydration, infusion of dexmedetomidine may keep the renal functions.

Official Title
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Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

Conditions
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Radiographic Contrast Agent Nephropathy

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: 0.9 % NaCl
* Drug: 0.9 % NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for percutaneous coronary angiography > 18 yo Diabetic patients Creatinin value < 3 mg/dl Exclusion Criteria: Contrast agent hypersensitivity Pregnant patients Creatinin value ≥3mg/dl patients have acute renal failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. 100 ml/10min 0.9 % NaCl administered intravenously just before the angiography. 1 ml/kg/h 0.9 % sodium chloride administered intravenously during the procedure and was continued 1 hour after the angiography. | Drug: 0.9 % NaCl<br>* During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.<br>* Other names: Normal Saline;Drug: 0.9 % NaCl<br>* 100 ml/10min infusion just before the angiography 1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure<br>* Other names: Normal Saline;|
| Active Comparator: Dexmedetomidine<br>Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography. 1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography. | Drug: Dexmedetomidine<br>* Intravenously 1μg/kg/10min administered just before the procedure. 1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography.<br>* Other names: Precedex;Drug: 0.9 % NaCl<br>* During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin |  | 1 day (from start of angioplasty till discharge from the hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 1 day (from start of angiography till discharge from the hospital) | 
| Heart rate |  | 1 day (from start of angiography till discharge from the hospital) | 
| Blood electrolyte levels ( sodium, potassium, chloride) |  | before the angiography and just before the discharge from hospital | 
| complete blood count |  | before the angiography and just before the discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine