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Remote Ischemic Preconditioning in Septic Patients (RIPC-ICU)

Primary Purpose

Critically Ill, Acute Kidney Injury, Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning (RIPC)
Sham RIPC
Sponsored by
Westfälische Wilhelms-Universität Münster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

Three cycles of 5- min upper limb sham ischemia.

Outcomes

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

Secondary Outcome Measures

Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Severity of AKI
The severity for AKI is classified according to the KDIGO criteria
Need for renal replacement therapy
Number of patients with renal replacement therapy
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
Mortality
Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
Length of Intensive Care Unit (ICU) stay
Length of hospital stay

Full Information

First Posted
March 30, 2023
Last Updated
June 20, 2023
Sponsor
Westfälische Wilhelms-Universität Münster
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1. Study Identification

Unique Protocol Identification Number
NCT05830669
Brief Title
Remote Ischemic Preconditioning in Septic Patients
Acronym
RIPC-ICU
Official Title
Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Westfälische Wilhelms-Universität Münster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Acute Kidney Injury, Sepsis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Three cycles of 5- min upper limb sham ischemia.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning (RIPC)
Intervention Description
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 Type
Procedure
Intervention Name(s)
Sham RIPC
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
Severity of AKI
Description
The severity for AKI is classified according to the KDIGO criteria
Time Frame
72 hours after the onset of sepsis
Title
Need for renal replacement therapy
Description
Number of patients with renal replacement therapy
Time Frame
72 hours after the onset of sepsis
Title
Recovery of kidney function
Description
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
Time Frame
day 90 after the onset of sepsis
Title
Mortality
Time Frame
day 90 after the onset of sepsis
Title
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
Title
Length of Intensive Care Unit (ICU) stay
Time Frame
up to 90 days after onset of sepsis
Title
Length of hospital stay
Time Frame
up to 90 days after onset of sepsis
Other Pre-specified Outcome Measures:
Title
Add-on Study (Analysis of further proteins)
Time Frame
from randomization until 24 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Meersch-Dini, MD
Phone
+49-251-8347255
Email
meersch@uni-muenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Meersch-Dini, MD
Organizational Affiliation
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meersch, MD
Email
aki@uni-muenster.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Ischemic Preconditioning in Septic Patients

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