Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06536231

Acronym

HERICA

Enrollment

Registered

2024-08-02

Start date

2024-01-01

Completion date

2025-03-31

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Remote ischemic conditioning, Passive leg raising, Hemodynamic, Perfusion index, Fluid responsiveness

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.

Interventions

PROCEDURERemote 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Lithuania

Contacts

Primary ContactAndrius Pranskunas, PhD, prof.

andrius.pranskunas@lsmu.lt+37037326425

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026