Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2023-05-11
2026-01-31
Brief Summary
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Remote ischemic preconditioning (RIPC) will be induced by three cycles of upper limb ischemia.
The aim of the study is to reduce the incidence of AKI by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7(IGFBP7)
Detailed Description
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Ischemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury.
The aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention Group
Remote ischemic preconditioning (RIPC) Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia.
Remote ischemic preconditioning (RIPC)
3 cycles of 5 min inflation of a blood-pressure cuff to 200 millimetres of mercury (mmHG) (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed.
Control Group
Three cycles of 5- min upper limb sham ischemia.
Sham RIPC
3 cycles of 5 min inflation of a blood-pressure cuff to 20 mmHG to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed
Interventions
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Remote ischemic preconditioning (RIPC)
3 cycles of 5 min inflation of a blood-pressure cuff to 200 millimetres of mercury (mmHG) (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed.
Sham RIPC
3 cycles of 5 min inflation of a blood-pressure cuff to 20 mmHG to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed
Eligibility Criteria
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Inclusion Criteria
* Critically ill patients with sepsis \< 12 hours
* Invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy
* Unrestricted intensive care for at least 72 hours
* Written informed consent
Exclusion Criteria
* (Glomerulo-)nephritis, interstitial nephritis, vasculitis
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m²
* Chronic dialysis dependency
* Kidney transplant in the last 12 months
* Oral antidiabetics, sulfonamides or nicorandil
* Pregnancy or breastfeeding
* Do-not-reanimate order
* Participation in another interventional trial involving kidney outcomes within the last 3 months
* Dependency on the investigator or center
18 Years
ALL
No
Sponsors
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Universität Münster
OTHER
Responsible Party
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Principal Investigators
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Melanie Meersch-Dini, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
Locations
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University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, , Germany
Countries
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Central Contacts
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Facility Contacts
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Meersch, MD
Role: primary
Other Identifiers
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AnIt22-06
Identifier Type: -
Identifier Source: org_study_id