- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315782
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis
Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rosa M Estrada-Y-Martin, MD MSc
- Phone Number: 713-500-6830
- Email: rosa.m.estrada.y.martin@uth.tmc.edu
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Memorial Hermann Hospital
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Contact:
- Rosa M Estrada-Y-Martin, MD MSc
- Phone Number: 713-500-6830
- Email: rosa.m.estrada.y.martin@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Multi-organ failure
Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multi-organ failure
Time Frame: daily for 48 hours then weekly for 2 weeks.
|
Multi-oran failure will be accessed by daily laboratory data, heart function by echocardiogram if available, urinary output, vitals and use of vasopressors.
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daily for 48 hours then weekly for 2 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: ICU mortality
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All the patient will be followed up to 28-days to determine survival.
|
ICU mortality
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rosa M Estrada-Y-Martin, MD MSc, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-10-0555
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