Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

NCT02137863 | Completed Phase 4

• 1 other identifier: 2011/345
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Contrast induced nephropathy; Diabetes Mellitus; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Dexmedetomidine

ACTIVE COMPARATOR

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; Drug: 0.9 % NaCl

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

0.9 % NaCl DRUG

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.

Also known as: Normal Saline

Control; Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for percutaneous coronary angiography
• \> 18 yo
• Diabetic patients
• Creatinin value \< 3 mg/dl

You may not qualify if:

• Contrast agent hypersensitivity
• Pregnant patients
• Creatinin value ≥3mg/dl
• patients have acute renal failure

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Aynur Akın, Prof

  TC Erciyes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: May 14, 2014
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 14, 2014

Record last verified: 2014-05