Status:
RECRUITING
Trendelenburg As a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients
Lead Sponsor:
Negovsky Reanimatology Research Institute
Conditions:
Hypotension
Shock
Eligibility:
All Genders
18+ years
Phase:
NA
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 vaso...
Detailed Description
Current consensus on circulatory shock management defines shock as a life-threatening, generalized form of acute circulatory failure associated with inadequate tissue perfusion. Recommended interventi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05209737
Start Date
January 31 2022
End Date
October 20 2026
Last Update
November 14 2024
Active Locations (2)
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1
Vishnevsky Center of Surgery
Moscow, Russia, 117997
2
Demikhov Municipal Clinical Hospital 68
Moscow, Russia