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VTE Incidence in Severe Sepsis and Septic Shock

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ClinicalTrials.gov Identifier: NCT02353910
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Matthew Rondina, MD, University of Utah

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
Severe Sepsis With Septic Shock Procedure: Ultrasound

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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 : July 2009
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock




Primary Outcome Measures :
  1. Incidence of VTE [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Rondina, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02353910    
Other Study ID Numbers: 1001
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes