VTE Incidence in Severe Sepsis and Septic Shock

February 2, 2015 updated by: Matthew Rondina, MD, University of Utah

VTE Incidence and Risk Factors in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We prospectively studied 113 consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients provided informed consent and this study was IRB approved. VTE thromboprophylaxis was recorded for all patients. Patients underwent bilateral lower (and upper, if a central venous catheter [CVC] was present) comprehensive compression ultrasonography (CUS) and were followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. We performed multivariate regression analyses to identify predictors of VTE

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of VTE
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001 (Registro Nacional Estudios Clinicos (RNEC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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