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RECRUITING

NCT05209737

Trendelenburg As a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients

Sponsor: Negovsky Reanimatology Research Institute

View on ClinicalTrials.gov

Summary

A pilot randomized controlled trial to evaluate the efficacy and safety of Trendelenburg position in critically ill patients with hypotension, mainly patients with septic shock and post operative vasoplegia. The main aim is to assess whether Trendelenburg position can improve organ function through a reduction in the need of fluid infusion and dose of vasopressors. Patients will be screened for participation in the study and eventually randomized based on a balanced randomization scheme (1:1) to Trendelenburg position up to 72 hours after intensive care unit (ICU) admission or Semirecumbent position (standard of care).

Official title: Trendelenburg As a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients: a Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-01-31

Completion Date

2026-10-20

Last Updated

2024-11-14

Healthy Volunteers

Conditions

Hypotension Shock

Interventions

PROCEDURE

Trendelenburg position

A 10-degree head-down position will be used in this group

PROCEDURE

Semirecumbent position

A 30-degree head-up position will be used in this group

Inclusion Criteria: * Age \>18 years * Admitted to the intensive care unit (ICU); * Invasive mechanical ventilation; * Pharmacological sedation; * Mean arterial pressure (MAP)\<65 mmHg or need of fluids infusion or any vasopressor in order to keep MAP \> 65 mmHg * Ongoing invasive and/or non-invasive arterial blood pressure monitoring * Central venous line with central venous pressure (CVP) monitoring * Naso-gastric tube in situ * Indwelling bladder catheter * Consent according to local ethical committee rules Exclusion Criteria: * Body mass index \> 45 * Documented or suspected increased intracranial pressure, based on medical history or actual clinical condition (es. intracranial tumor, cerebral hemorrhage, encephalitis,...); * Intra-abdominal hypertension \>25 mmHg * Documented or suspected increased intraocular pressure (any degree of glaucoma) * Full stomach pyloric incontinence; * Gastric stasis, defined as aspiration from the NG (nasogastric) tube of fecal, bloody, or green fluid greater than 100 mL upon insertion of the tube or within the preceding hour; * Ongoing enteral nutrition * No central line inserted or femoral central line only * Not sutured known diaphragm lesions * Known hiatus hernia * Aortic bifurcation and/or lower extremity arterial stenosis ≥70% combined with stage 3 intermittent claudication (pain at rest) * Patients who are not able to be investigated with a leg raising test (eg lower extremities fractures, backbone fractures or backbone pain or deformity, and those patients with large cannulas in the femoral vessels) * Demand of specific postures (eg Trauma, fractures, backbone pain or deformity, patients with large cannulas in the femoral vessels, pronation including first pronation planned within 6 h…) * Any device which, according to the clinician, makes it unfeasible or unsafe to put patients in the Trendelenburg position (eg Drainage in thoracic cavity) * Mechanical Circulatory Support; * (CHD) (Gleen, Fontaine); * Advanced right ventricular dysfunction or advanced cardiac failure, in which volume overload worsens cardiac function (plateau stage in the Frank-Starling curve); * Actual upper gastrointestinal bleeding * Passive leg raising test non-responder

Locations (2)

Vishnevsky Center of Surgery

Moscow, Russia

Demikhov Municipal Clinical Hospital 68