TerminatedNot Applicable

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

Stopped: Recruiting problems

Russia10 participantsStarted 2022-01-31

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 d…

What they're measuring

Time to severe hypotension resolution

Timeframe: 72 hours

Trial details

NCT IDNCT05209737

SponsorNegovsky Reanimatology Research Institute

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-10-20