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Clinical Trials/NCT06536231
NCT06536231
Recruiting
Not Applicable

Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

Lithuanian University of Health Sciences1 site in 1 country50 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Lithuanian University of Health Sciences
Enrollment
50
Locations
1
Primary Endpoint
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.

Detailed Description

The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR). Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrius Pranskunas

prof.

Lithuanian University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • aged over 18 years,
  • admitted to the intensive care unit,
  • monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
  • decision by the physician in charge to perform passive leg raising.

Exclusion Criteria

  • pregnancy,
  • advanced malignancy,
  • peripheral artery disease affecting both arms,
  • head trauma,
  • deep vein thrombosis in the lower limbs,
  • intra-abdominal hypertension, defined as an intra-abdominal pressure greater than 12 mmHg.

Outcomes

Primary Outcomes

Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure

Time Frame: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff.

Maximal change in cardiac index during RIC procedure

Time Frame: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff.

Maximal change in peripheral perfusion index during RIC procedure

Time Frame: During RIC procedure

Change in this parameter is determined during each inflation and release of the blood pressure cuff. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR).

Time Frame: During RIC procedure, as well as during passive leg raising.

The maximum changes in these parameters, as determined by the RIC procedure and PLR, were identified, and their correlation was subsequently calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure.

Time Frame: During PLR both before and after the RIC procedure.

The maximum changes in these parameters, as measured during PLR before and after the RIC procedure, were identified. Subsequently, the correlation between these changes was calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.

Secondary Outcomes

  • The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR.(During RIC procedure, as well as during PLR.)

Study Sites (1)

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