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NCT Number: NCT05830669

Remote Ischemic Preconditioning in Septic Patients

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)

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Key information

Conditions

Critically Ill Acute Kidney Injury Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Münster, 48149, Germany

Location status: Recruiting

Location contact

Meersch, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic preconditioning (RIPC)

Procedure

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.

Sham RIPC

Procedure

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 outcomes

  1. 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

  1. 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

  2. Severity of AKI

    Time frame: 72 hours after the onset of sepsis

    The severity for AKI is classified according to the KDIGO criteria

  3. Need for renal replacement therapy

    Time frame: 72 hours after the onset of sepsis

    Number of patients with renal replacement therapy

  4. Recovery of kidney function

    Time frame: 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

  5. Mortality

    Time frame: day 90 after the onset of sepsis

  6. 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

  7. Length of Intensive Care Unit (ICU) stay

    Time frame: up to 90 days after onset of sepsis

  8. Length of hospital stay

    Time frame: up to 90 days after onset of sepsis

Other outcomes

  1. Add-on Study (Analysis of further proteins)

    Time frame: from randomization until 24 hours after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Meersch-Dini, MD

CONTACT

[email protected]

+49-251-8347255

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Registry information

Official study title

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

Acronym: RIPC-ICU

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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