Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Phase 4

Completed

• Conditions: Radiographic Contrast Agent Nephropathy
• Interventions: Drug: 0.9 % NaCl; Drug: Dexmedetomidine

• Registration Number: NCT02137863
• Lead Sponsor: TC Erciyes University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Study First Submitted: 2014-01-13
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Study First Posted: 2014-05-14
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	0.9 % NaCl	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.
Dexmedetomidine	0.9 % NaCl	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.
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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