Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness: A Comprehensive Crossover Study Examination

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hypotension is a significant precursor to unfavorable clinical outcomes. To determine whether infusion therapy can positively impact the management of hypotension, several evaluative tests can be utilized. These include assessing the collapsibility and distensibility indices of the inferior vena cava, conducting a passive leg raising (PLR) test, and performing a fluid challenge (FC). Technologically advanced methods leveraging dynamic testing are capable of real-time prediction of a patient's response to infusion therapy. Nonetheless, the use of systolic pressure variability (SPV), pulse pressure variability (PPV), and stroke volume variability (SVV) is often limited by the prohibitive costs of the necessary equipment. In contrast, the PLR test and FC are not subject to this limitation. Despite being deemed unreliable by numerous clinical protocols, static measurements of central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) persist in usage among certain traditionalists within the medical community. It must be noted that the patient's baseline state and the unique clinical context are pivotal in determining the precision of these methodologies. For example, the PLR test may yield limited information in fully conscious patients, and the prognostic value of CVP measurements is significantly diminished in cases of pneumothorax and hydrothorax. Regrettably, there is a paucity of data on the prognostic utility of these tests in patients with altered levels of consciousness, despite their growing presence in intensive care units. This gap underscores the necessity for comprehensive studies that evaluate the predictive efficacy of infusion therapy responsiveness in patients with concurrent hypotension and impaired consciousness. Purpose of the study: to investigate the sensitivity and specificity of methods for assessing fluid responsiveness in patients with hypotension and decreased level of consciousness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Hospitalization in an intensive care unit

• Level of consciousness on the FOUR scale ≤ 12 points

• Presence of arterial hypotension

• Presence of a central venous catheter or direct indication for catheterization

• The decision of the medical council to include the patient in the study

Locations
Other Locations
Russian Federation
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
RECRUITING
Moscow
Contact Information
Primary
Valery Likhvantsev, PhD
lik0704@gmail.com
+79036235982
Backup
Levan Berikashvili, MD
levan.berikashvili@mail.ru
+79263308968
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2026-05-20
Participants
Target number of participants: 222
Treatments
Experimental: Fluid responsiveness testing
In our clinical study to evaluate infusion therapy responsiveness, we'll start by measuring the inferior vena cava diameter. Two minutes later, we'll assess central venous pressure. After another two-minute pause, the passive leg raise test begins, followed by a 15-minute wait. Then, we conduct the fluid challenge. Post-evaluation, we administer balanced crystalloid solutions at 1000 ml, infused at 15 ml/kg/h, adjusting for any previous infusions during the fluid challenge.
Related Therapeutic Areas
Sponsors
Leads: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

This content was sourced from clinicaltrials.gov