Clinical trial NCT05830669: Remote Ischemic Preconditioning in Septic Patients
Official title: Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critically Ill
Acute Kidney Injury
Sepsis
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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)

Detailed description: Acute kidney injury (AKI) is a common complication in critically ill patients with sepsis. To date, there is no pharmacological option to treat or prevent AKI.

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.

Eligibility criteria: 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 outcomes:
measure: 1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization
timeFrame: from randomization to 24 hours after randomization
Secondary outcomes:
measure: Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
timeFrame: 72 hours after the onset of sepsis
measure: Severity of AKI
timeFrame: 72 hours after the onset of sepsis
measure: Need for renal replacement therapy
timeFrame: 72 hours after the onset of sepsis
measure: Recovery of kidney function
timeFrame: day 90 after the onset of sepsis
measure: Mortality
timeFrame: day 90 after the onset of sepsis
measure: Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
timeFrame: day 90 after the onset of sepsis
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: up to 90 days after onset of sepsis
measure: Length of hospital stay
timeFrame: up to 90 days after onset of sepsis
Other outcomes:
measure: Add-on Study (Analysis of further proteins)
timeFrame: from randomization until 24 hours after randomization
Locations:
city: Münster
country: Germany
facility: University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
name: Melanie Meersch-Dini, MD
role: PRINCIPAL_INVESTIGATOR
References: