Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients (Trend)
Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients: a Pilot Randomized Controlled Trial
Sponsor: Negovsky Reanimatology Research Institute
Terminated
Recruiting problems
Other Hypotension trials with similar outcome
This observational or N/A phase trial investigates Hypotension and Shock and is currently terminated or withdrawn. Negovsky Reanimatology Research Institute leads this study, which shows 9 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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...
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.
Status Flow
Change History
9 versions recorded-
Apr 16, 2026 — Present [daily]
Terminated
Status: Recruiting → Terminated · Phase: NA → None
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Sep 2025 — Apr 2026 [monthly]
Recruiting NA
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Dec 2024 — Sep 2025 [monthly]
Recruiting NA
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Sep 2024 — Dec 2024 [monthly]
Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Recruiting NA
▶ Show 4 earlier versions
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Feb 2024 — Jul 2024 [monthly]
Recruiting NA
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Dec 2023 — Feb 2024 [monthly]
Recruiting NA
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Dec 2022 — Dec 2023 [monthly]
Recruiting NA
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Feb 2022 — Dec 2022 [monthly]
Recruiting NA
First recorded
Jan 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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).
Contact Information
- Negovsky Reanimatology Research Institute
For direct contact, visit the study record on ClinicalTrials.gov .