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Clinical 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. 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05209737
Study type Interventional
Source Negovsky Reanimatology Research Institute
Contact Valery Likhvantsev
Phone +79036235982
Email [email protected]
Status Recruiting
Phase N/A
Start date January 31, 2022
Completion date October 20, 2022

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