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Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department

Primary Purpose

Contrast-induced Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ischemic preconditioning
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring Contrast-induced nephropathy, Ischemic preconditioning

Eligibility Criteria

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

Inclusion Criteria:

  • Participants, older than 18 years old and received contrast enhanced CT scan in the emergency medicine department
  • The Mehran Risk Score is greater than 5 points

Exclusion Criteria:

  • The Mehran Risk Score is under 6 points
  • Participants who doesn't want to enroll the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Study group

    Sham group

    Arm Description

    Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

    Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

    Outcomes

    Primary Outcome Measures

    Percentage of Participants developing contrast-induced nephropathy
    %25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement

    Secondary Outcome Measures

    renal replacement theraphy
    renal failure necessitating renal replacement therapy

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    July 31, 2017
    Sponsor
    Derince Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03238391
    Brief Title
    Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department
    Official Title
    Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department: Randomised, Double Blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 15, 2017 (Anticipated)
    Primary Completion Date
    February 15, 2018 (Anticipated)
    Study Completion Date
    February 15, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Derince Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in the emergency department to prevent contrast induced nephropathy
    Detailed Description
    The research will be conducted of emergency medicine department in The Derince Training and Research Hospital. Patients ages 18 and older, who will be received contrast enhanced CT scan in the emergency medicine department will be included to the study. Patients will be excluded from the study if The Mehran Risk Score is under 6 points. The Mehran Risk Score is a scoring system for prediction of contrast-induced nephropathy. This CIN (Contrast induced nephropathy) risk stratification score based on 8 variables. The variables included in the CIN risk score are: 1) patient-related characteristics (i.e., age >75 years, diabetes mellitus, chronic congestive heart failure, or admission with acute pulmonary edema, hypotension, anemia, and chronic kidney disease); and 2) procedure related characteristics (i.e., the use of elective IABP (Intra aortic balloon pump) or increasing volumes of contrast media). It is categorized into 4 groups according to MRS (Mehran Risk Score) (low-risk: 5 (7.5%); medium-risk: 6-10 (14%); high-risk: 11-16 (26.1%); and very high-risk: 16 (57.3%).Normal salin at a rate of 3 mL/kg/hour per 1 hour before contrast agents exposure followed by 1 mL/kg/hour for 6 hours after the procedure is administered whose Mehran risk score is greater than 6 in our daily practice. Patients with risk factors for CIN are recommended about the necessity of follow-up care with their physicians within 48-72 hours. Patients with low risk of contrast induced nephropathy, previous allergic reactions to contrast material, hemodynamically unstable and require excessive fluid resuscitation, undergoing surgical procedures, require renal-replacement therapy, who refuse to participate the study will be excluded. All of the emergency medicine physicians will be informed of the study. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program (www.randomization.com) generating an online random number. All participating patients will receive the standard hydration schedule as mentioned before. Patients in the study group will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times. Patients in sham group, will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times. The allocation sequence will be concealed from the researchers and participants in sealed, sequentially numbered envelopes. Envelopes will be opened by the nurse who will administer the protocol. Less than 100 mL of nonionic, hypoosmolar contrast agent will be injected in all CT scans.All of the participants will be recommended about the necessity of follow-up care with their physicians within 48-72 hours. Participants will be called 72 hours after the treatment. Patients who are diagnosed with CIN will be followed for one month to see whether they will develop renal failure requiring renal replacement therapy. After 72 hours the laboratory results will be recorded by the researchers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contrast-induced Nephropathy
    Keywords
    Contrast-induced nephropathy, Ischemic preconditioning

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times
    Arm Title
    Sham group
    Arm Type
    Sham Comparator
    Arm Description
    Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times
    Intervention Type
    Procedure
    Intervention Name(s)
    Ischemic preconditioning
    Intervention Description
    It is mentioned before in arm/group descriptions
    Primary Outcome Measure Information:
    Title
    Percentage of Participants developing contrast-induced nephropathy
    Description
    %25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement
    Time Frame
    48 to 72 hours
    Secondary Outcome Measure Information:
    Title
    renal replacement theraphy
    Description
    renal failure necessitating renal replacement therapy
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants, older than 18 years old and received contrast enhanced CT scan in the emergency medicine department The Mehran Risk Score is greater than 5 points Exclusion Criteria: The Mehran Risk Score is under 6 points Participants who doesn't want to enroll the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yavuz Yigit, Specialist
    Phone
    +90 505 6628344
    Email
    dryavuzyigit@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    15939688
    Citation
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    15616393
    Citation
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    Citation
    Barreto R. Prevention of contrast-induced nephropathy: the rational use of sodium bicarbonate. Nephrol Nurs J. 2007 Jul-Aug;34(4):417-21.
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    PubMed Identifier
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    Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department

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