Remote Ischemic Preconditioning in Septic Patients

Sepsis Clinical Trial

— RIPC-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830669
• Other study ID #: AnIt22-06
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: January 2025

Study information

• Verified date: June 2023
• Source: Westfälische Wilhelms-Universität Münster
• Contact: Melanie Meersch-Dini, MD
• Phone: +49-251-8347255
• Email: meersch[@]uni-muenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Critically Ill
• Sepsis

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Westfälische Wilhelms-Universität Münster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Add-on Study (Analysis of further proteins)		from randomization until 24 hours after randomization
Primary	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	Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria		72 hours after the onset of sepsis
Secondary	Severity of AKI	The severity for AKI is classified according to the KDIGO criteria	72 hours after the onset of sepsis
Secondary	Need for renal replacement therapy	Number of patients with renal replacement therapy	72 hours after the onset of sepsis
Secondary	Recovery of kidney function	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	day 90 after the onset of sepsis
Secondary	Mortality		day 90 after the onset of sepsis
Secondary	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
Secondary	Length of Intensive Care Unit (ICU) stay		up to 90 days after onset of sepsis
Secondary	Length of hospital stay		up to 90 days after onset of sepsis