Preconditioning Against Renal Damage Under Contrast Examination
Re-DUCE-F
1 other identifier
interventional
1,000
1 country
1
Brief Summary
This study aims to assess if applying an ischaemic insult to an arm before giving intravenous contrast will help decrease the incidence of developing contrast induced acute renal injury in patients undergoing contrast-enhanced CT Scans. The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans, does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and reperfusion, when compared to control, reduce the proportion of patients developing contrast-induced acute kidney injury in the first 3 post-scan days? '.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 4, 2014
February 1, 2014
1.2 years
February 3, 2014
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in estimated glomerular filtration rate(eGFR) using RIPC
Our primary research objective is to determine whether RIPC induced using brief arm ischaemia and reperfusion reduces the proportion of patients who develop a reduction in estimated glomerular filtration rate(eGFR) ≥20% in the first 3 days following CT scan
3 days post scan
Secondary Outcomes (7)
Length of hospital stay
30 days
Length of intensive care stay
30 days
Numbers of unplanned critical care admissions
30 days
Renal impariment after 1 year
1 year
Recruitment potential for phase 3 study
15 months
- +2 more secondary outcomes
Study Arms (2)
RIPC
EXPERIMENTALPreconditioning will be performed in the same manner as several previous trials. Immediately prior to having the CT scan a CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure \>185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles.
Control
NO INTERVENTIONPatients randomised to this group will receive routine care associated with undergoing a CT scan.
Interventions
Remote ischaemic preconditioning (RIPC) is a simple technique whereby brief periods of skeletal muscle ischaemia and reperfusion triggers a period of resistance to ischaemia-reperfusion injury in distant tissues eg. heart or kidney. In this study preconditioning will be performed Immediately prior to the patient undergoing a CT scan. A CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure \>185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles.
Eligibility Criteria
You may qualify if:
- All medical and surgical in-patients aged 40-yrs or over scheduled to undergo contrast-enhanced CT scans.
- Patients willing to give full informed consent for participation
You may not qualify if:
- Pregnancy
- Significant upper limb peripheral arterial disease
- Previous history of upper limb deep vein thrombosis
- Patients on glibenclamide or nicorandil (these medications may interfere with RIPC)
- Patients with an estimated pre-operative glomerular filtration rate \<30mls/min/1.73m2
- Patients with a known history of myocarditis, pericarditis or amyloidosis
- Patients who have received intravenous contrast in the previous year
- Patients with severe hepatic disease defined as a an international normalised ratio \>2 in the absence of systemic anticoagulation
- Patients previously enrolled in the trial representing a further scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Limerick
Limerick, Limerick, 00, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stewart R Walsh, MCh FRCS
University Hospital of Limerick
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery and Consultant Vascular Surgeon
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 4, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
February 4, 2014
Record last verified: 2014-02