Evaluation of Serial Ultrasound Screening in ICU COVID-19 Patients

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05028244

Collaborator

(none)

170

Enrollment

Location

Arms

8.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial is destinated 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 lenght of stay in the hospital, along with other outcomes.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: venous ultrasound of lower extremity	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Evaluation of Serial Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in Patients With COVID-19 Admitted to Intensive Care.

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Selected patients undego lower extremity ultrasound for diagnosis of deep vein thrombosis 2 times per week (mondays and thursdays) in a period of 3 weeks (21 days) of follow up	Diagnostic Test: venous ultrasound of lower extremity Patients inbed are explored for deep vein thrombosis in femoral-popliteal and distal veins of the legs with ultrasound compresión and doppler flow evaluation
No Intervention: control group This group only undergo the first ultrasound assesment to discard previos thrombosis not detected during hospitalization or ambulatory

Arm

Intervention/Treatment

Experimental: Intervention group

Selected patients undego lower extremity ultrasound for diagnosis of deep vein thrombosis 2 times per week (mondays and thursdays) in a period of 3 weeks (21 days) of follow up

Diagnostic Test: venous ultrasound of lower extremity

Patients inbed are explored for deep vein thrombosis in femoral-popliteal and distal veins of the legs with ultrasound compresión and doppler flow evaluation

No Intervention: control group

This group only undergo the first ultrasound assesment to discard previos thrombosis not detected during hospitalization or ambulatory