VTE Incidence in Severe Sepsis and Septic Shock

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02353910
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 113

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis With Septic Shock	Procedure: Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 113 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2014

Outcome Measures

Primary Outcome Measures

1. Incidence of VTE [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Utah
• National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Rondina, MD, Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT02353910
• Other Study ID Numbers: 1001
• First Posted: Feb 3, 2015
• Last Update Posted: Feb 3, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock

Study Results

No Results Posted as of Feb 3, 2015