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Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

This study is not yet open for participant recruitment.
Verified May 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01315782
First received: March 8, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure.

The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention.


Condition
Sepsis
Severe Sepsis
Septic Shock
Multi-organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Multi-organ failure [ Time Frame: daily for 48 hours then weekly for 2 weeks. ] [ Designated as safety issue: No ]
    Multi-oran failure will be accessed by daily laboratory data, heart function by echocardiogram if available, urinary output, vitals and use of vasopressors.


Secondary Outcome Measures:
  • Mortality [ Time Frame: ICU mortality ] [ Designated as safety issue: No ]
    All the patient will be followed up to 28-days to determine survival.


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Multi-organ failure
Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock.

Detailed Description:

The patient will be followed during their ICU stay up to two weeks while on mechanical ventilation.

Patient will be followed daily for the initial 48 hours and then once per week for 2 weeks while mechanically ventilated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients admitted to medical intensive care unit with severe sepsis or septic shock requiring mechanical ventilation.

Criteria

Inclusion Criteria:

  • Adults with severe sepsis or septic shock on mechanical ventilation
  • Enrolled in the initial six hours of ICU admission

Exclusion Criteria:

  • Patients with withdrawal or hospice order.
  • Patients with terminal, irreversible disease, expect to decease in 48 hours from ICU admission.
  • Patients with COPD.
  • Patients transferred from outside ICU with ongoing sepsis management for more than six hours.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315782

Contacts
Contact: Rosa M Estrada-Y-Martin, MD MSc 713-500-6830 rosa.m.estrada.y.martin@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Rosa M Estrada-Y-Martin, MD MSc The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Rosa Estrada Y Martin, Associate Professor - IM, Critical Care, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01315782     History of Changes
Other Study ID Numbers: HSC-MS-10-0555
Study First Received: March 8, 2011
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Sepsis
Severe sepsis
Septic shock
Alveolar dead space
Multi-organ failure

Additional relevant MeSH terms:
Multiple Organ Failure
Sepsis
Toxemia
Shock
Shock, Septic
 Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 21, 2013