Critically IllRIPC-ICUNCT05830669
Remote Ischemic Preconditioning in Septic Patients
A study testing Remote ischemic preconditioning (RIPC) in people with Critically Ill and Acute Kidney Injury, run by Universität Münster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Acute Kidney Injury, Sepsis
- What is being tested?
- Remote ischemic preconditioning (RIPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, 48149
Meersch, MD, aki@uni-muenster.de
About this study
Official title: Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
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)
Read the 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.
- Conditions
- Critically Ill, Acute Kidney Injury, Sepsis
- Being tested
- Remote ischemic preconditioning (RIPC), Sham RIPC
- Medical subject headings
- Critical Illness, Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning (RIPC)Procedure or surgery
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 RIPCProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Remote ischemic preconditioning (RIPC) |
| Control Group | Sham comparator | Three cycles of 5- min upper limb sham ischemia. Receives: Procedure: Sham RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 hours after the onset of sepsis
Severity of AKI
The severity for AKI is classified according to the KDIGO criteria
Measured: 72 hours after the onset of sepsis
Need for renal replacement therapy
Number of patients with renal replacement therapy
Measured: 72 hours after the onset of sepsis
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
Measured: day 90 after the onset of sepsis
Mortality
Measured: 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
Measured: day 90 after the onset of sepsis
Length of Intensive Care Unit (ICU) stay
Measured: up to 90 days after onset of sepsis
Length of hospital stay
Measured: up to 90 days after onset of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start11 May 2023
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Meersch-Dini, MD, Principal investigator, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830669
- Sponsor's protocol ID
- AnIt22-06
- Acronym
- RIPC-ICU
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05830669
- Acronym / sponsor ID
- RIPC-ICU / AnIt22-06
- Conditions
- Critically Ill, Acute Kidney Injury, Sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Remote ischemic preconditioning (RIPC)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. |
| Control Group | Sham comparator | Procedure: Sham RIPCThree cycles of 5- min upper limb sham ischemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Intervention Group |
| Sham RIPC3 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 | Procedure or surgery | Control Group |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Meersch-Dini, MD principal investigator
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning (RIPC) in people with Critically Ill and Acute Kidney Injury, run by Universität Münster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Meersch-Dini, MD (+49-251-8347255, meersch@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.