- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644926
The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis
February 28, 2021 updated by: Andrius Pranskunas, Lithuanian University of Health Sciences
Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital.
Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission.
Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes.
The procedure overall took 30 minutes.
RIC is performed at inclusion and repeated 12 h and 24 h later.
Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kaunas, Lithuania, LT-50161
- Hospital of Lithuanian University of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with sepsis or septic shock within the first 24 h after ICU admission.
Exclusion Criteria:
- age < 18 years,
- pregnancy,
- advanced malignancy,
- peripheral artery disease affecting both arms,
- oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remote ischemic conditioning
Remote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later.
|
Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes.
The procedure overall took 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
Time Frame: 30 minutes
|
The differences in MFI and PPV between pre- and post-RIC performance.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
November 19, 2020
First Submitted That Met QC Criteria
November 19, 2020
First Posted (Actual)
November 25, 2020
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
February 28, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE-2-78
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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