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Clinical Trials in Germany / NCT05830669
Recruiting Not applicable

Remote Ischemic Preconditioning in Septic Patients

NCT05830669 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2023-05-11
Last updated
2024-12-12

Condition(s) studied

Critically IllAcute Kidney InjurySepsis

Investigational drug(s) / intervention(s)

Remote ischemic preconditioning (RIPC)Sham RIPC

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05830669 on ClinicalTrials.gov ↗ ← All trials in Germany