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NCT04644926 Clinical Trial

The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

Sepsis Clinical Trial

Official title:
Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04644926
Other study ID # BE-2-78
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 1, 2018
Est. completion date September 1, 2020

Study information
Verified date February 2021
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Remote ischemic conditioning
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.

Locations
Country Name City State
Lithuania Hospital of Lithuanian university of health sciences Kaunas

Sponsors (1)
Lead Sponsor Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV) The differences in MFI and PPV between pre- and post-RIC performance. 30 minutes
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