NCT04644926

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

November 19, 2020

Last Update Submit

February 28, 2021

Conditions

Septic ShockSepsis

Keywords

MicrocirculationRemote ischemic conditioningSepsis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Remote ischemic conditioning

EXPERIMENTAL

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

Procedure: Remote ischemic conditioning

Interventions

Remote ischemic conditioningPROCEDURE

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.

Remote ischemic conditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sepsis or septic shock within the first 24 h after ICU admission.

You may not qualify if:

  • age \< 18 years,
  • pregnancy,
  • advanced malignancy,
  • peripheral artery disease affecting both arms,
  • oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Lithuanian university of health sciences

Kaunas, LT-50161, Lithuania

Location

Related Publications (1)

  • 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.

    PMID: 33829305DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

February 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)