The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

NCT ID: NCT04644926

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock Sepsis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote ischemic conditioning

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

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Andrius Pranskunas

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital of Lithuanian university of health sciences

Kaunas, , Lithuania

Site Status

Countries

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Lithuania

References

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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.

Reference Type DERIVED
PMID: 33829305 (View on PubMed)

Other Identifiers

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BE-2-78

Identifier Type: -

Identifier Source: org_study_id

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