The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

Lithuanian University of Health Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Septic Shock; Sepsis

Treatments: Procedure: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT04644926

BE-2-78

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Remote ischemic conditioning

Experimental group

Description:

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

Treatment:

Procedure: Remote ischemic conditioning