Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients (HERICA)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: Remote ischemic conditioning

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrius Pranskunas, PhD, prof.; Phone Number: +37037326425; Email: andrius.pranskunas@lsmu.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania, 50161
    • Recruiting
    • The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care
    • Contact: Andrius Pranskunas, PhD, prof.
    • Principal Investigator: Andrius Pranskunas, PhD, prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Passive leg raising and Remote ischemic conditioning; Supine position was followed by the passive leg raising (PLR) maneuver. After completing the PLR test, participants were placed in the supine position for 5 min. Thereafter, remote ischemic conditioning (RIC) was performed. After the RIC procedure, the patient is left in supine position for 5 minutes. Then the PLR test was repeated, after which the participants were placed in a supine position for another 5 min at rest. When the patient fluid responder, physician in charge may decide to perform a fluid infusion (500 mL of crystaloids). The PLR test can also be performed to make decision for fluid removal. This decision is triggered by a negative PLR test in the later phase of ICU treatment. If the physician has decided to administer a fluids, systemic hemodynamics and peripheral perfusion index are measured immediately after completion of the fluid infusion.

Procedure: Remote 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure	Change in this parameter is determined during each inflation and release of the blood pressure cuff.	During RIC procedure
Maximal change in cardiac index during RIC procedure	Change in this parameter is determined during each inflation and release of the blood pressure cuff.	During RIC procedure
Maximal change in peripheral perfusion index 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.	During RIC procedure
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).	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.	During RIC procedure, as well as during passive leg raising.
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.	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.	During PLR both before and after the RIC procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During RIC procedure, as well as during PLR.

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Andrius Pranskunas, PhD, prof., Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Hemodynamic; Fluid responsiveness; Perfusion index; Remote ischemic conditioning; Passive leg raising
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 1.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No