HypotensionTrendNCT05209737
Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients
A study testing Trendelenburg position and Semirecumbent position in people with Hypotension and Shock, run by Negovsky Reanimatology Research Institute at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Shock
- What is being tested?
- Trendelenburg position and Semirecumbent position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesRussia
- Study dates
- 31 Jan 2022to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Central venous line with central venous pressure (CVP) monitoring
- Naso-gastric tube in situ
- Indwelling bladder catheter
- Consent according to local ethical committee rules
Who cannot join
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Vishnevsky Center of Surgery
Moscow, 117997
Demikhov Municipal Clinical Hospital 68
Moscow
About this study
Official title: Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients: a Pilot Randomized Controlled Trial
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).
Read the 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 interventions to improve perfusion include early hemodynamic stabilization through fluid resuscitation, along with treatment of the cause of shock. If impaired cardiac function results in inadequate cardiac output and tissue hypoperfusion despite fluid therapy, vasopressor agents should be administered.
Nevertheless, fluid overload causes multi-organ edema, such as pulmonary edema or hepatic congestion. Moreover, the negative effects of fluid intravenous administrations were also studied on healthy volunteers during the years. Most of them showed the development of lung injury due to fluid administration.
In addition, vasopressors are also associated with poor outcomes. Described serious adverse effects include organ ischemia, tachyarrhythmias, and atrial fibrillation, leading to organ dysfunction and mortality.
The head-down position, also known as the Trendelenburg position, was originally used by the surgeon Friederich Trendelenburg to improve surgical exposure of pelvic organs. The Trendelenburg position became then a widely popular procedure in managing patients with hypotension and shock. The primary effect of the Trendelenburg position is an increase in cardiac output. Although the short term effect on blood pressure and CO is certain, there is no agreement on its benefit in terms of tissue perfusion and clinical outcome in critically ill hypotensive patients, as nobody has attempted the Trendelenburg position as first line management.
To date, the gold standard position for patients in ICU according to the latest ESICM guidelines to prevent ventilator-associated pneumonia is the semirecumbent position. Experts recommend elevating the head of the patient on the bed to a 20-45 degrees position, preferably >30 degrees position.
Critically ill patients with hypotension, mainly patients with septic shock and those with post-operative vasoplegia, may be a subgroup of patients, who would benefit from a head-down position if the risks of aspiration pneumonia are minimized. The Trendelenburg position might permit to avoid the deleterious side effects of fluids and vasoconstrictor administration.
The idea is that Trendelenburg position can improve organ function through a reduction in the need of fluid infusion and doses of vasopressors in hypovolemic, hypotensive ICU patients and therefore increase ventilator free days.
The main aim of this trial is to assess if Trendelenburg position can reduce time to severe hypotension resolution.
- Conditions
- Hypotension, Shock
- Being tested
- Trendelenburg position, Semirecumbent position
- Keywords
- Trendelenburg position, hypotension, hypovolemic shock, shock, head-down position
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positionProcedure or surgery
A 10-degree head-down position will be used in this group
Semirecumbent positionProcedure or surgery
A 30-degree head-up position will be used in this group
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg position | Experimental | Position: 10-degree Head-down position Receives: Procedure: Trendelenburg position |
| Semirecumbent position | Active comparator | Position: 30-degree Head-up position Receives: Procedure: Semirecumbent position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (8)
Ventilator-free days at 28 days
28 days - number of days in which the mechanical lung ventilation was not used
Measured: 28 days
ICU-free days at 28 days
28 days - number of days in which the patient was not in an intensive care unit
Measured: 28 days
Restarting vasopressor/inotrope therapy
Using vasopressors and/or inotropes to maintain MAP ≥ 65 mm Hg after premature study termination (Vasoactive inotrope score > 5)
Measured: 28 days
28-days mortality
all cause mortality
Measured: 28 days
90-days mortality
all cause mortality
Measured: 90 days
Acute kidney injury
number of patients who have acute kidney injury according to KDIGO classification
Measured: 28 days
Acute liver failure
Rapid hepatic injury with coagulation derangements and hepatic encephalopathy and multi-organ failure in a patient with no history of liver disease
Measured: 28 days
Ventilation-associated pneumonia
Pneumonia due to mechanical lung ventilation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start31 Jan 2022
- Primary completion20 Oct 2025
- Study completion20 Nov 2025
Why it stopped: Recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Negovsky Reanimatology Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery Likhvantsev, MD, Negovsky Reanimatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209737
- Sponsor's protocol ID
- Trend
- Acronym
- Trend
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05209737
- Acronym / sponsor ID
- Trend / Trend
- Conditions
- Hypotension, Shock
- Keywords
- Trendelenburg position, hypotension, hypovolemic shock, shock, head-down position
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting problems
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Negovsky Reanimatology Research InstituteOther government
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 interventions to improve perfusion include early hemodynamic stabilization through fluid resuscitation, along with treatment of the cause of shock. If impaired cardiac function results in inadequate cardiac output and tissue hypoperfusion despite fluid therapy, vasopressor agents should be administered.
Nevertheless, fluid overload causes multi-organ edema, such as pulmonary edema or hepatic congestion. Moreover, the negative effects of fluid intravenous administrations were also studied on healthy volunteers during the years. Most of them showed the development of lung injury due to fluid administration.
In addition, vasopressors are also associated with poor outcomes. Described serious adverse effects include organ ischemia, tachyarrhythmias, and atrial fibrillation, leading to organ dysfunction and mortality.
The head-down position, also known as the Trendelenburg position, was originally used by the surgeon Friederich Trendelenburg to improve surgical exposure of pelvic organs. The Trendelenburg position became then a widely popular procedure in managing patients with hypotension and shock. The primary effect of the Trendelenburg position is an increase in cardiac output. Although the short term effect on blood pressure and CO is certain, there is no agreement on its benefit in terms of tissue perfusion and clinical outcome in critically ill hypotensive patients, as nobody has attempted the Trendelenburg position as first line management.
To date, the gold standard position for patients in ICU according to the latest ESICM guidelines to prevent ventilator-associated pneumonia is the semirecumbent position. Experts recommend elevating the head of the patient on the bed to a 20-45 degrees position, preferably >30 degrees position.
Critically ill patients with hypotension, mainly patients with septic shock and those with post-operative vasoplegia, may be a subgroup of patients, who would benefit from a head-down position if the risks of aspiration pneumonia are minimized. The Trendelenburg position might permit to avoid the deleterious side effects of fluids and vasoconstrictor administration.
The idea is that Trendelenburg position can improve organ function through a reduction in the need of fluid infusion and doses of vasopressors in hypovolemic, hypotensive ICU patients and therefore increase ventilator free days.
The main aim of this trial is to assess if Trendelenburg position can reduce time to severe hypotension resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg position | Experimental | Procedure: Trendelenburg positionPosition: 10-degree Head-down position |
| Semirecumbent position | Active comparator | Procedure: Semirecumbent positionPosition: 30-degree Head-up position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg positionA 10-degree head-down position will be used in this group | Procedure or surgery | Trendelenburg position |
| Semirecumbent positionA 30-degree head-up position will be used in this group | Procedure or surgery | Semirecumbent position |
Primary outcome
Time to severe hypotension resolution
Time frame: 72 hours
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
8 secondary outcomes
Ventilator-free days at 28 days
Time frame: 28 days
ICU-free days at 28 days
Time frame: 28 days
Restarting vasopressor/inotrope therapy
Time frame: 28 days
28-days mortality
Time frame: 28 days
90-days mortality
Time frame: 90 days
Acute kidney injury
Time frame: 28 days
Acute liver failure
Time frame: 28 days
Ventilation-associated pneumonia
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg position and Semirecumbent position in people with Hypotension and Shock, run by Negovsky Reanimatology Research Institute at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to severe hypotension resolution (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.