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Recruiting NCT05830669

Remote Ischemic Preconditioning in Septic Patients

No phase Interventional Critically Ill Acute Kidney Injury Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote ischemic preconditioning (RIPC), Sham RIPC.
Who it may be relevant to
Registry conditions: Critically Ill, Acute Kidney Injury, Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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

Primary outcome measures

  • 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 outcome measures (8)
  • Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria [Time frame: 72 hours after the onset of sepsis]
  • Severity of AKI [Time frame: 72 hours after the onset of sepsis]
  • Need for renal replacement therapy [Time frame: 72 hours after the onset of sepsis]
  • Recovery of kidney function [Time frame: day 90 after the onset of sepsis]
  • Mortality [Time frame: 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 [Time frame: day 90 after the onset of sepsis]
  • Length of Intensive Care Unit (ICU) stay [Time frame: up to 90 days after onset of sepsis]
  • Length of hospital stay [Time frame: up to 90 days after onset of sepsis]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pai — Münster

Identifiers

NCT: NCT05830669 · AnIt22-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗