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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

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

• 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

Locations
Other Locations
Russian Federation
Demikhov Municipal Clinical Hospital 68
RECRUITING
Moscow
Vishnevsky Center of Surgery
RECRUITING
Moscow
Contact Information
Primary
Valery Likhvantsev
lik0704@gmail.com
+79036235982
Backup
Levan Berikashvili
levan.berikashvili@mail.ru
+79263308968
Time Frame
Start Date: 2022-01-31
Estimated Completion Date: 2026-10-20
Participants
Target number of participants: 50
Treatments
Experimental: Trendelenburg position
Position: 10-degree Head-down position
Active_comparator: Semirecumbent position
Position: 30-degree Head-up position
Related Therapeutic Areas
Sponsors
Leads: Negovsky Reanimatology Research Institute

This content was sourced from clinicaltrials.gov