Evaluation of Serial Ultrasound Screening in ICU COVID-19 Patients

NCT05028244 | Completed

• 1 other identifier: P/R(AG)176/2021
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Mortality

  Patients that die in ICU during follow up

  21 days

• ICU Stay

  Number of days staying in that unit during follow up

  21 days

• Symptomatic deep venous thrombosis

  presence of confirmed deep vein thrombosis and presence of symptoms

  21 days

Secondary Outcomes (1)

• composite outcome

  21 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Selected patients undergo 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

control group

NO INTERVENTION

This group only undergo the first ultrasound assessment to discard previous thrombosis not detected during hospitalisation or ambulatory

Interventions

venous ultrasound of lower extremity DIAGNOSTIC_TEST

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (25)

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  PMID: 39838947 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; COVID-19; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Sergi Bellmunt Montoya

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: August 31, 2021
• Study Start: April 1, 2021
• Primary Completion: August 15, 2021
• Study Completion: December 13, 2021
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)