Remote Ischemic Preconditioning in Septic Patients

Not Applicable

Recruiting

• Conditions: Critically Ill; Sepsis; Acute Kidney Injury
• Interventions: Procedure: Sham RIPC; Procedure: Remote ischemic preconditioning (RIPC)

• Registration Number: NCT05830669
• Lead Sponsor: Universität Münster

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 Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Study Start: 2023-05-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham RIPC	Three cycles of 5- min upper limb sham ischemia.
Intervention Group	Remote ischemic preconditioning (RIPC)	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.

Primary Outcome Measures

Name	Time	Method
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	from randomization to 24 hours after randomization

Secondary Outcome Measures

Name	Time	Method
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	The severity for AKI is classified according to the KDIGO criteria
Need for renal replacement therapy	72 hours after the onset of sepsis	Number of patients with renal replacement therapy
Recovery of kidney function	day 90 after the onset of sepsis	defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine \>0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent
Mortality	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

Trial Locations

Locations (1)

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