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
About this trial
This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring Contrast-induced nephropathy, Ischemic preconditioning
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
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
NCT ID
NCT03238391
First Posted
July 31, 2017
Last Updated
July 31, 2017
Sponsor
Derince Training and Research Hospital
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
Citations:
PubMed Identifier
15939688
Citation
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Citation
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Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department
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