VTE Incidence in Severe Sepsis and Septic Shock

NCT02353910 | Completed

• 1 other identifier: 1001
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Sepsis With Septic Shock

Outcome Measures

Primary Outcomes (1)

• Incidence of VTE

  28 days

Interventions

Ultrasound PROCEDURE

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ICU patients with severe sepsis and septic shock

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator

Related Publications (1)

• Kaplan D, Casper TC, Elliott CG, Men S, Pendleton RC, Kraiss LW, Weyrich AS, Grissom CK, Zimmerman GA, Rondina MT. VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock. Chest. 2015 Nov;148(5):1224-1230. doi: 10.1378/chest.15-0287.

  PMID: 26111103 DERIVED

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 3, 2015
• Study Start: July 1, 2009
• Primary Completion: December 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-01