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The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

Phase 1
Completed
Conditions
Sepsis
Septic Shock
Registration Number
NCT04644926
Lead Sponsor
Lithuanian University of Health Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)30 minutes

The differences in MFI and PPV between pre- and post-RIC performance.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hospital of Lithuanian university of health sciences

🇱🇹

Kaunas, Lithuania

Hospital of Lithuanian university of health sciences
🇱🇹Kaunas, Lithuania
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