Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

Not Applicable

Recruiting

• Conditions: Critical Illness

• Registration Number: NCT06536231
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Study First Posted: 2024-08-02
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure	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	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	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).	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.	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 Outcome Measures

Name	Time	Method
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.	In this context, PI is measured on the arm where the blood pressure cuff is placed. Upon cuff release, both the maximum PI and the time to reach this maximum are recorded.

Trial Locations

Locations (1)

The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care; 🇱🇹 Kaunas, Lithuania