Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

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.

Study Overview

• Status: Completed
• Conditions: Radiographic Contrast Agent Nephropathy
• Intervention / Treatment: Drug: 0.9 % NaCl; Drug: 0.9 % NaCl; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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; 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.; Other Names: Normal Saline; Drug: 0.9 % NaCl; 100 ml/10min infusion just before the angiography 1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure; Other Names: Normal Saline
Active Comparator: 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.	Drug: 0.9 % NaCl; 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.; Other Names: Normal Saline; Drug: 0.9 % NaCl; 100 ml/10min infusion just before the angiography 1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure; Other Names: Normal Saline; Drug: Dexmedetomidine; 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.; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Chair: Aynur Akın, Prof, TC Erciyes University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Dexmedetomidine; Contrast induced nephropathy
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2011/345