Remote Organ Ischemic PreconditioningNCT04216407
The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters
A study testing Remote ischemic preconditioning in people with Remote Organ Ischemic Preconditioning, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remote Organ Ischemic Preconditioning
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients followed up by Acıbadem Hospital Organ Transplantation Center
- Patients accepted to participate in the study
- Older than 18 years of age
- ASA class III
- MELD score >12
- Scheduled for elective liver transplantation surgery from a living donor
Who cannot join
- Patients undergoing re-transplantation
- Under the age of 18 years
- Patients undergoing emergency surgery
- Patients with hepatorenal or hepatopulmonary syndrome
- Patients receiving mechanical ventilation support in the ICU
- Patients refusing to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
Istanbul, Atakent, 34303
About this study
Official title: The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients
Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.
- Conditions
- Remote Organ Ischemic Preconditioning
- Being tested
- Remote ischemic preconditioning
- Keywords
- Remote organ ischemic preconditioning, Ischemia reperfusion injury, Glycocalyx integrity parameters, Systemic inflammation parameters
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
An orthopedic tourniquet was tied to the right lower extremities of the patients in RIPC arm, and tourniquet application was performed before the anhepatic phase in 3 periods of 3 minutes with an interval of 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | Short-term tourniquet on to the lower extremity before surgery Receives: Procedure: Remote ischemic preconditioning |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor necrosis factor-alpha (TNF-alpha)
Evaluation of TNF-alpha level difference between groups
Measured: Postoperative early period (6 hours after intensive care unite admission)
Intercellular adhesion molecule-1 (ICAM-1)
Evaluation of (ICAM-1) level difference between group
Measured: Postoperative early period (6 hours after intensive care unite admission)
Hypoxia-induced factor-1 (HIF-1)
Evaluation of HIF-1 level difference between groups
Measured: Postoperative early period (6 hours after intensive care unite admission)
Interleukin-8 (IL-8)
Evaluation of IL-8 level difference between groups
Measured: Postoperative early period (6 hours after intensive care unite admission)
Syndecan-1 (SDC-1)
Evaluation of SDC-1 level difference between groups
Measured: Postoperative early period (6 hours after intensive care unite admission)
soluble Vascular cell adhesion molecule-1 (sVCAM-1).
Evaluation of sVCAM-1 level difference between groups
Measured: Postoperative early period (6 hours after intensive care unite admission)
Secondary outcomes (4)
Mortality
Early postoperative mortality
Measured: 7 days after surgery
Liver function tests
Evaluation of early postoperative liver function tests; AST and ALT
Measured: 7 days after surgery
Length of stay in hospital and intensive care unit
Evaluation of the length of stay in hospital and intensive care unit
Measured: 7 days after surgery
Morbidity
Early postoperative complications
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start5 Dec 2019
- Primary completion17 Jan 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote Organ Ischemic PreconditioningStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216407
- Sponsor's protocol ID
- 2019-01/02
- Status last verified
- Apr 2020
- First submitted
- 25 Dec 2019
- Last updated
- 8 Apr 2020
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients
- ClinicalTrials.gov ID
- NCT04216407
- Acronym / sponsor ID
- 2019-01/02
- Conditions
- Remote Organ Ischemic Preconditioning
- Keywords
- Remote organ ischemic preconditioning, Ischemia reperfusion injury, Glycocalyx integrity parameters, Systemic inflammation parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 2 Jan 2020 (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.
Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | Procedure: Remote ischemic preconditioningShort-term tourniquet on to the lower extremity before surgery |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients followed up by Acıbadem Hospital Organ Transplantation Center
- Patients accepted to participate in the study
- Older than 18 years of age
- ASA class III
- MELD score >12
Key exclusion criteria (6 listed)
- Patients undergoing re-transplantation
- Under the age of 18 years
- Patients undergoing emergency surgery
- Patients with hepatorenal or hepatopulmonary syndrome
- Patients receiving mechanical ventilation support in the ICU
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 preconditioningAn orthopedic tourniquet was tied to the right lower extremities of the patients in RIPC arm, and tourniquet application was performed before the anhepatic phase in 3 periods of 3 minutes with an interval of 3 minutes. | Procedure or surgery | Remote Ischemic Preconditioning |
Primary outcome
Tumor necrosis factor-alpha (TNF-alpha)
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of TNF-alpha level difference between groups
Intercellular adhesion molecule-1 (ICAM-1)
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of (ICAM-1) level difference between group
Hypoxia-induced factor-1 (HIF-1)
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of HIF-1 level difference between groups
Interleukin-8 (IL-8)
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of IL-8 level difference between groups
Syndecan-1 (SDC-1)
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of SDC-1 level difference between groups
soluble Vascular cell adhesion molecule-1 (sVCAM-1).
Time frame: Postoperative early period (6 hours after intensive care unite admission)
Evaluation of sVCAM-1 level difference between groups
4 secondary outcomes
Mortality
Time frame: 7 days after surgery
Liver function tests
Time frame: 7 days after surgery
Length of stay in hospital and intensive care unit
Time frame: 7 days after surgery
Morbidity
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Remote Organ Ischemic Preconditioning
Recruiting
Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
Aortic Dissection Type A
Not yet recruiting
Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Cardiopulmonary Bypass, Cardiovascular Diseases
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Remote Organ Ischemic Preconditioning, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 8 Apr 2020. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor necrosis factor-alpha (TNF-alpha) (time frame: Postoperative early period (6 hours after intensive care unite admission)). The study lists 6 primary outcomes in all. 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 8 Apr 2020.