- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016857
Remote Ischemic Preconditioning During Lower Limb Revascularization
September 27, 2021 updated by: Alberto Noto, University of Messina
Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization
The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.
Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Messina, Italy, 98100
- A.O.U. G.Martino - University of Messina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for open limb revascularization
Exclusion Criteria:
- Peripheral vascular disease affecting upper limbs
- Chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
- Patients underwent contrast-enhanced radiological exams in the previous 7 days
- Treatment with glibencamide or prostaglandins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RIPC Group
Remote ischemic preconditioning
|
4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
|
SHAM_COMPARATOR: Control Group
Sham remote ischemic preconditioning
|
deflated cuff placed on the left arm for 40 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AKI
Time Frame: 72 Hours
|
the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative
|
72 Hours
|
AKI
Time Frame: 72 Hours
|
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
|
72 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AKI Risk Score
Time Frame: 24 Hours
|
the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)
|
24 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alberto Noto, MD, PhD, University of Messina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2018
Primary Completion (ACTUAL)
January 15, 2019
Study Completion (ACTUAL)
June 15, 2019
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (ACTUAL)
July 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 4, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMEANE1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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