VTE Incidence in Severe Sepsis and Septic Shock

Severe Sepsis With Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353910
• Other study ID #: 1001
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: February 2, 2015
• Start date: July 2009

Study information

• Verified date: January 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis With Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of VTE		28 days	No