Remote Ischemic Preconditioning in Septic Patients (RIPC-ICU)

Universität Münster

Status: Enrolling

Conditions: Critically Ill; Acute Kidney Injury; Sepsis

Treatments: Procedure: Remote ischemic preconditioning (RIPC); Procedure: Sham RIPC

Study type: Interventional

Funder types: Other

Identifiers

NCT05830669

AnIt22-06

Details and patient eligibility

About

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)

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning (RIPC)

Control Group

Sham Comparator group

Description:

Three cycles of 5- min upper limb sham ischemia.

Treatment:

Procedure: Sham RIPC