Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137863
• Other study ID #: 2011/345
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2014
• Last updated: May 13, 2014
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	blood pressure		1 day (from start of angiography till discharge from the hospital)	No
Secondary	Heart rate		1 day (from start of angiography till discharge from the hospital)	No
Secondary	Blood electrolyte levels ( sodium, potassium, chloride)		before the angiography and just before the discharge from hospital	No
Secondary	complete blood count		before the angiography and just before the discharge from hospital	No