Skip to main content
OpenTrials
Completed

NCT Number: NCT04644926

The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital of Lithuanian university of health sciences

Kaunas, LT-50161, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Ischemic conditioning

Procedure

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.