Clinical trial NCT06536231: Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
Official title: Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Remote ischemic conditioning
Passive leg raising
Hemodynamic
Perfusion index
Fluid responsiveness
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure
timeFrame: During RIC procedure
measure: Maximal change in cardiac index during RIC procedure
timeFrame: During RIC procedure
measure: Maximal change in peripheral perfusion index during RIC procedure
timeFrame: During RIC procedure
measure: 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).
timeFrame: During RIC procedure, as well as during passive leg raising.
measure: 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.
timeFrame: During PLR both before and after the RIC procedure.
Secondary outcomes:
measure: 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.
timeFrame: During RIC procedure, as well as during PLR.
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Andrius Pranskunas, PhD, prof.
role: PRINCIPAL_INVESTIGATOR
References: