Ischemic PreconditioningNCT04016857
Remote Ischemic Preconditioning During Lower Limb Revascularization
A study testing RIPC in people with Ischemic Preconditioning and Acute Kidney Injury, run by University of Messina at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for open limb revascularization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia
- Being tested
- RIPC, Control
- Keywords
- remote ischemic preconditioning, lower limb revascularization, TIMP-2, IGFBP-7
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
ControlProcedure or surgery
deflated cuff placed on the left arm for 40 min
| Study group | Role | What they receive |
|---|---|---|
| RIPC Group | Experimental | Remote ischemic preconditioning Receives: Procedure: RIPC |
| Control Group | Sham comparator | Sham remote ischemic preconditioning Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI
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
Measured: 72 Hours
AKI
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
Measured: 72 Hours
Secondary outcomes (1)
AKI Risk Score
the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7)
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start15 Jan 2018
- Primary completion15 Jan 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Noto, University of Messina
- Investigators
- Alberto Noto, MD, PhD, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016857
- Sponsor's protocol ID
- UMEANE1
- Status last verified
- Sep 2021
- First submitted
- 8 Jul 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization
- ClinicalTrials.gov ID
- NCT04016857
- Acronym / sponsor ID
- UMEANE1
- Conditions
- Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia
- Keywords
- remote ischemic preconditioning, lower limb revascularization, TIMP-2, IGFBP-7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
| Arm | Type | Receives |
|---|---|---|
| RIPC Group | Experimental | Procedure: RIPCRemote ischemic preconditioning |
| Control Group | Sham comparator | Procedure: ControlSham remote ischemic preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for open limb revascularization
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPC4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff | Procedure or surgery | RIPC Group |
| Controldeflated cuff placed on the left arm for 40 min | Procedure or surgery | Control Group |
Primary outcome
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
AKI
Time frame: 72 Hours
the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.
1 secondary outcome
AKI Risk Score
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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Effects of Remote Ischemic Preconditioning at Different Time Phases in Patients Undergoing Heart Valve Surgery
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
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Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Noto, MD, PhD principal investigator
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Ischemic Preconditioning and Acute Kidney Injury, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI (time frame: 72 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.