Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Radiographic Contrast Agent Nephropathy

Treatments: Drug: Dexmedetomidine; Drug: 0.9 % NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT02137863

2011/345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9 % NaCl

Drug: 0.9 % NaCl

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9 % NaCl

Drug: 0.9 % NaCl

Drug: Dexmedetomidine