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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Conditions
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
Primary outcomes
-
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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