Remote Ischemic Preconditioning in Septic Patients

NCT05830669 | Recruiting

• 1 other identifier: AnIt22-06
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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)

Conditions

Critically Ill; Acute Kidney Injury; Sepsis

Outcome Measures

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

  from randomization to 24 hours after randomization

Secondary Outcomes (8)

• 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

• Mortality

  day 90 after the onset of sepsis

Other Outcomes (1)

• Add-on Study (Analysis of further proteins)

  from randomization until 24 hours after randomization

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Procedure: Remote ischemic preconditioning (RIPC)

Control Group

SHAM COMPARATOR

Three cycles of 5- min upper limb sham ischemia.

Procedure: Sham RIPC

Interventions

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.

Intervention Group

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (1)

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

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Melanie Meersch-Dini, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Meersch-Dini, MD

CONTACT

+49-251-8347255; meersch@uni-muenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 26, 2023
• Study Start: May 11, 2023
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)