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

NCT05209737 | Terminated DMC

• 1 other identifier: Trend
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Hypotension; Shock

Keywords

Trendelenburg position; hypotension; hypovolemic shock; shock; head-down position

Outcome Measures

Primary Outcomes (1)

• Time to severe hypotension resolution

  Time from randomization to timepoint in which MAP \> 65 mmHg not requiring fluids or vasoactive drugs (VIS \< 5), lasting \> 1 hour, in the semirecumbent position

  72 hours

Secondary Outcomes (8)

• Ventilator-free days at 28 days

  28 days

• ICU-free days at 28 days

  28 days

• Restarting vasopressor/inotrope therapy

  28 days

• 28-days mortality

  28 days

• 90-days mortality

  90 days

Study Arms (2)

Trendelenburg position

EXPERIMENTAL

Position: 10-degree Head-down position

Procedure: Trendelenburg position

Semirecumbent position

ACTIVE COMPARATOR

Position: 30-degree Head-up position

Procedure: Semirecumbent position

Interventions

Trendelenburg position PROCEDURE

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

Trendelenburg position

Semirecumbent position PROCEDURE

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

Semirecumbent position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Negovsky Reanimatology Research Institute: lead

Study Sites (2)

Vishnevsky Center of Surgery

Moscow, 117997, Russia

Location

Demikhov Municipal Clinical Hospital 68

Moscow, Russia

Location

MeSH Terms

Conditions

Hypotension; Shock

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research V. Negovsky Reanimatology Research Institute

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 31, 2022
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)