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NCT Number: NCT06536231

Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kaunas, 50161, Lithuania

Location status: Recruiting

Location contact

Andrius Pranskunas, PhD, prof.

CONTACT

Andrius Pranskunas, PhD, prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure

    Time frame: During RIC procedure

    Change in this parameter is determined during each inflation and release of the blood pressure cuff.

  2. Maximal change in cardiac index during RIC procedure

    Time frame: During RIC procedure

    Change in this parameter is determined during each inflation and release of the blood pressure cuff.

  3. Maximal change in peripheral perfusion index during RIC procedure

    Time frame: 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.

  4. 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).

    Time frame: 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.

  5. 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.

    Time frame: 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 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrius Pranskunas, PhD, prof.

CONTACT

[email protected]

+37037326425

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Acronym: HERICA

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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