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Recruiting NCT06536231

Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

No phase Interventional Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote ischemic conditioning.
Who it may be relevant to
Registry conditions: Critical Illness. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lithuania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • 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.

Primary outcome measures

  • Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure [Time frame: During RIC procedure]
  • Maximal change in cardiac index during RIC procedure [Time frame: During RIC procedure]
  • Maximal change in peripheral perfusion index during RIC procedure [Time frame: 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). [Time frame: 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. [Time frame: During PLR both before and after the RIC procedure.]
Secondary outcome measures (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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Lithuania · 1 center
  • The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Int — Kaunas

Identifiers

NCT: NCT06536231 · 1.2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗