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Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Primary Purpose

Radiographic Contrast Agent Nephropathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
0.9 % NaCl
0.9 % NaCl
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Control

    Dexmedetomidine

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin

    Secondary Outcome Measures

    blood pressure
    Heart rate
    Blood electrolyte levels ( sodium, potassium, chloride)
    complete blood count

    Full Information

    First Posted
    January 13, 2014
    Last Updated
    May 13, 2014
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02137863
    Brief Title
    Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy
    Official Title
    Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiographic Contrast Agent Nephropathy
    Keywords
    Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm 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.
    Arm Title
    Dexmedetomidine
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    Precedex
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    0.9 % NaCl
    Other Intervention Name(s)
    Normal Saline
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    0.9 % NaCl
    Other Intervention Name(s)
    Normal Saline
    Intervention Description
    100 ml/10min infusion just before the angiography 1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure
    Primary Outcome Measure Information:
    Title
    Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
    Time Frame
    1 day (from start of angioplasty till discharge from the hospital)
    Secondary Outcome Measure Information:
    Title
    blood pressure
    Time Frame
    1 day (from start of angiography till discharge from the hospital)
    Title
    Heart rate
    Time Frame
    1 day (from start of angiography till discharge from the hospital)
    Title
    Blood electrolyte levels ( sodium, potassium, chloride)
    Time Frame
    before the angiography and just before the discharge from hospital
    Title
    complete blood count
    Time Frame
    before the angiography and just before the discharge from hospital

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aynur Akın, Prof
    Organizational Affiliation
    TC Erciyes University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

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