Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients

Hypotension Clinical Trial

— Trend  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209737
• Other study ID #: Trend
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: October 20, 2024

Study information

• Verified date: January 2024
• Source: Negovsky Reanimatology Research Institute
• Contact: Valery Likhvantsev
• Phone: +79036235982
• Email: lik0704[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hypotension
• Shock

Intervention

Procedure:
• Trendelenburg position
A 10-degree head-down position will be used in this group
• Semirecumbent position
A 30-degree head-up position will be used in this group

Locations

Country	Name	City	State
Russian Federation	Demikhov Municipal Clinical Hospital 68	Moscow
Russian Federation	Vishnevsky Center of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Negovsky Reanimatology Research Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours
Secondary	Ventilator-free days at 28 days	28 days - number of days in which the mechanical lung ventilation was not used	28 days
Secondary	ICU-free days at 28 days	28 days - number of days in which the patient was not in an intensive care unit	28 days
Secondary	Restarting vasopressor/inotrope therapy	Using vasopressors and/or inotropes to maintain MAP = 65 mm Hg after premature study termination (Vasoactive inotrope score > 5)	28 days
Secondary	28-days mortality	all cause mortality	28 days
Secondary	90-days mortality	all cause mortality	90 days
Secondary	Acute kidney injury	number of patients who have acute kidney injury according to KDIGO classification	28 days
Secondary	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	28 days
Secondary	Ventilation-associated pneumonia	Pneumonia due to mechanical lung ventilation	28 days