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OpenTrials
Completed

NCT Number: NCT02353910

VTE Incidence in Severe Sepsis and Septic Shock

Prospective studies on the incidence of VTE during severe sepsis and septic shock remain absent, hindering efficacy assessments regarding current VTE prevention strategies in septic patients. The investigators will prospectively study consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients will provide informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per standard of care and according to the patients' primary team, will be recorded for all patients. Patients will undergo bilateral lower (and upper, if a central venous catheter [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The investigators will perform multivariate regression analyses to identify predictors of VTE.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU patients with severe sepsis and septic shock

Exclusion criteria

  • Admission diagnosis of acute VTE,
  • age < 13 years,
  • pregnancy,
  • severe chronic respiratory disease,
  • severe chronic liver disease (Child-Pugh Score of 11-15),
  • moribund patients not expected to survive 24 hours, and
  • acute myocardial infarction within 30 days.

Treatment and study plan

Ultrasound

Procedure

Primary outcomes

  1. Incidence of VTE

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock

Important dates

Study start
2009
Primary completion
2014
First posted
Feb 3, 2015
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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