Severe Sepsis With Septic ShockNCT02353910
VTE Incidence in Severe Sepsis and Septic Shock
An observational study of Severe Sepsis With Septic Shock, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Severe Sepsis With Septic Shock
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- ICU patients with severe sepsis and septic shock
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Severe Sepsis With Septic Shock
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VTE
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJul 2009
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Sepsis With Septic ShockStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Matthew Rondina, MD, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353910
- Sponsor's protocol ID
- 1001
- Status last verified
- Jan 2015
- First submitted
- 23 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
Publications
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.
PubMed 26111103
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT02353910
- Acronym / sponsor ID
- 1001
- Conditions
- Severe Sepsis With Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- Dec 2014 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- ICU patients with severe sepsis and septic shock
Key exclusion criteria (7 listed)
- Admission diagnosis of acute VTE,
- age < 13 years,
- pregnancy,
- severe chronic respiratory disease,
- severe chronic liver disease (Child-Pugh Score of 11-15),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound | Procedure or surgery | – |
Primary outcome
Incidence of VTE
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 26111103Kaplan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis With Septic Shock, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of VTE (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.