Skip to content

VTE Incidence in Severe Sepsis and Septic Shock

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02353910
Enrollment
113
Registered
2015-02-03
Start date
2009-07-31
Completion date
Unknown
Last updated
2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis With Septic Shock

Brief summary

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.

Interventions

PROCEDUREUltrasound

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of VTE28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026