Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

NCT ID: NCT06536231

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Andrius Pranskunas

prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrius Pranskunas, PhD, prof.

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

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

Kaunas, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Andrius Pranskunas, PhD, prof.

Role: CONTACT

andrius.pranskunas@lsmu.lt

+37037326425

Facility Contacts

Andrius Pranskunas, PhD, prof.

Role: primary

Other Identifiers

1.2

Identifier Type: -

Identifier Source: org_study_id