VTE Incidence in Severe Sepsis and Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Severe Sepsis With Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No