Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universität Münster
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Remote ischemic preconditioning (RIPC) (Procedure)
Control Group
Three cycles of 5- min upper limb sham ischemia.
Intervention: Sham RIPC (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: from randomization to 24 hours after randomization
Secondary Outcomes
- Mortality(day 90 after the onset of sepsis)
- Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more(day 90 after the onset of sepsis)
- Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(72 hours after the onset of sepsis)
- Severity of AKI(72 hours after the onset of sepsis)
- Need for renal replacement therapy(72 hours after the onset of sepsis)
- Recovery of kidney function(day 90 after the onset of sepsis)
- Length of Intensive Care Unit (ICU) stay(up to 90 days after onset of sepsis)
- Length of hospital stay(up to 90 days after onset of sepsis)