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The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

Primary Purpose

Septic Shock, Sepsis

Status
Completed
Phase
Phase 1
Locations
Lithuania
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Microcirculation, Remote ischemic conditioning, Sepsis

Eligibility Criteria

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

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.

Sites / Locations

  • Hospital of Lithuanian university of health sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote ischemic conditioning

Arm Description

Remote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later.

Outcomes

Primary Outcome Measures

Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
The differences in MFI and PPV between pre- and post-RIC performance.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2020
Last Updated
February 28, 2021
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04644926
Brief Title
The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis
Official Title
Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

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
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Sepsis
Keywords
Microcirculation, Remote ischemic conditioning, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Experimental
Arm Description
Remote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
Description
The differences in MFI and PPV between pre- and post-RIC performance.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital of Lithuanian university of health sciences
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33829305
Citation
Kiudulaite I, Belousoviene E, Vitkauskiene A, Pranskunas A. Effects of remote ischemic conditioning on microcirculatory alterations in patients with sepsis: a single-arm clinical trial. Ann Intensive Care. 2021 Apr 7;11(1):55. doi: 10.1186/s13613-021-00848-y.
Results Reference
derived

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The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

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