RecruitingNot ApplicableNCT05830669

Remote Ischemic Preconditioning in Septic Patients

Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial


Sponsor

Universität Münster

Enrollment

64 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Acute kidney injury is a well-recognized complication in critically ill patients. Up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury. 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)


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Adult patients (age ≥18 years)
  • 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 Criteria10

  • Pre-existing AKI
  • (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

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Interventions

PROCEDURERemote 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.

PROCEDURESham 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


Locations(1)

University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine

Münster, Germany

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NCT05830669


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