Clinical trial NCT05028244: Evaluation of Serial Ultrasound Screening in ICU COVID-19 Patients
Official title: Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients With Severe COVID-19: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Acute Respiratory Distress Syndrome
COVID-19 Acute Bronchitis
COVID-19 Lower Respiratory Infection
Pulmonary Embolism
Keywords: covid19
pulmonary embolism
intensive care unit
deep venous thrombosis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2021-08-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The selected patients undergo an ultrasound of lower extremity to discard previous thrombosis episodes. Then they are randomized to an intervention group (serial screening of deep venous thrombosis in lower extremity 2 times per week) or control group (no other exploration or interventions are made).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial is designed to evaluate if the periodic screening for deep venous thrombosis by ultrasound of lower extremity in patients with intensive care unit (ICU) patients with COVID 19 impacts on mortality, ICU stay and total length of stay in the hospital, along with other outcomes.

Detailed description: Background: COVID-19 has a high incidence of venous thromboembolic disease (VTE), especially pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), with an even higher incidence in patients admitted to the intensive care unit (ICU). The presentation of these events is related to an increase in mortality and the mean stay in the ICU. The impact of systematic screening for asymptomatic lower extremity DVT in these patients has not been studied, so we propose to carry out a clinical trial to assess its impact in these patients.

Hypothesis: Serial DVT screening in patients admitted to the ICU for COVID-19 does not improve survival, mean stay, or the incidence of symptomatic VTE.

Objective: To study whether DVT screening in these patients has an impact on the incidence of symptomatic VTE, mortality and average stay in the ICU.

Methods: Non-blind randomized clinical trial on all patients aged 18 years or older admitted to the ICU for COVID-19 with less than 72 hours elapsed since their admission to the unit. Patients with DVT or PE will be excluded at the time of recruitment (all patients will be ruled out by routine ultrasound and computed tomography angiography (CT Angiography)); Pregnant patients, patients with a previous diagnosis of DVT or PE, and patients undergoing extracorporeal membrane oxygenation (ECMO) will also be excluded. Patients will be randomized into two arms at the time of inclusion: the screened group (Group 1) and the non-screened group (Group 2). Group 1: patients who will be treated according to the usual ICU protocol and, additionally, will undergo serial ultrasounds of the lower extremities twice a week (Monday and Thursday). Group 2: they will be treated according to the usual ICU protocol and no screening examinations will be performed. Patients will be followed until discharge from the ICU or death and up to a maximum of 3 weeks. The incidence of symptomatic VTE will be assessed, as well as all-cause mortality and days of stay in the ICU. Clinical and laboratory variables will be collected from each patient for subsequent statistical analysis.

Relevance: The thrombotic complications of COVID-19 are well described, as well as their high incidence in critically ill patients. This work aims to clarify the current doubts about the need for systematic DVT screening in these patients. If our hypothesis is verified, a limited resource such as ultrasound of the lower limbs could be saved, as well as the use of the necessary protection materials and, most importantly, avoid unnecessary exposure of health personnel with the consequent risk that it represents for other professionals and patients.

Eligibility criteria: Inclusion Criteria:

* COVID 19 patients in their first 72 hours of entering ICU

Exclusion Criteria:

* Pregnant patients
* Not COVID 19 confirmed patients by RCP
* Patients that are in Extracorporeal membrane oxygenation
* Patients with previous thrombotic disease

Primary outcomes:
measure: Mortality
timeFrame: 21 days
measure: ICU Stay
timeFrame: 21 days
measure: Symptomatic deep venous thrombosis
timeFrame: 21 days
Secondary outcomes:
measure: composite outcome
timeFrame: 21 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Sergi Bellmunt Montoya
role: PRINCIPAL_INVESTIGATOR
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