Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

NCT06536231 | Recruiting

• 1 other identifier: 1.2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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 Arms (1)

Passive leg raising and Remote ischemic conditioning

EXPERIMENTAL

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

Interventions

Remote ischemic conditioning PROCEDURE

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.

Passive leg raising and Remote ischemic conditioning

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care

Kaunas, 50161, Lithuania

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrius Pranskunas, PhD, prof.

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrius Pranskunas, PhD, prof.

CONTACT

+37037326425; andrius.pranskunas@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

LI (1)