Using Trendelenburg position to treat critically ill patients with low blood pressure

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

This study is testing if putting critically ill patients with low blood pressure in a specific lying position can help improve their organ function and reduce the need for extra fluids and medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Negovsky Reanimatology Research Institute (Government)
• Locations: 2 sites (Moscow and 1 other locations)
• Trial ID: NCT05209737 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial evaluates the efficacy and safety of the Trendelenburg position in critically ill patients experiencing hypotension, particularly those with septic shock and postoperative vasoplegia. Participants will be randomized to either the Trendelenburg position or a semirecumbent position, with the aim of assessing improvements in organ function and reductions in fluid and vasopressor requirements. The study focuses on patients admitted to the intensive care unit who are invasively mechanically ventilated and sedated.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old who are admitted to the ICU, require invasive mechanical ventilation, and have low mean arterial pressure.

Not a fit: Patients with a body mass index over 45 or those with conditions like increased intracranial pressure or intra-abdominal hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for fluid infusions and vasopressors, potentially improving patient outcomes in critical care settings.

How similar studies have performed: While the Trendelenburg position has been widely used, this specific approach in critically ill patients with hypotension is novel and has not been extensively tested in recent studies.

Eligibility criteria

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

Where this trial is running

Moscow and 1 other locations

• Vishnevsky Center of Surgery — Moscow, Russian Federation (Recruiting)
• Demikhov Municipal Clinical Hospital 68 — Moscow, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Valery Likhvantsev

Conditions Hypotension; Shock; Trendelenburg position; hypotension; hypovolemic shock; shock; head-down position