SepsisNCT01315782
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis
An observational study of Sepsis and Severe Sepsis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to medical intensive care unit with severe sepsis or septic shock requiring mechanical ventilation.
Who may be able to join
- Adults with severe sepsis or septic shock on mechanical ventilation
- Enrolled in the initial six hours of ICU admission
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Hermann Hospital
Houston, Texas, 77030
Rosa M Estrada-Y-Martin, MD MSc, 713-500-6830, rosa.m.estrada.y.martin@uth.tmc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock, Multi-organ Failure
- Keywords
- Sepsis, Severe sepsis, Septic shock, Alveolar dead space, Multi-organ failure
- Medical subject headings
- Sepsis, Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multi-organ failure | Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-organ failure
Multi-oran failure will be accessed by daily laboratory data, heart function by echocardiogram if available, urinary output, vitals and use of vasopressors.
Measured: daily for 48 hours then weekly for 2 weeks.
Secondary outcomes (1)
Mortality
All the patient will be followed up to 28-days to determine survival.
Measured: ICU mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
- Investigators
- Rosa M Estrada-Y-Martin, MD MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315782
- Sponsor's protocol ID
- HSC-MS-10-0555
- Status last verified
- Jun 2025
- First submitted
- 8 Mar 2011
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01315782
- Acronym / sponsor ID
- HSC-MS-10-0555
- Conditions
- Sepsis, Severe Sepsis, Septic Shock, Multi-organ Failure
- Keywords
- Sepsis, Severe sepsis, Septic shock, Alveolar dead space, Multi-organ failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Mar 2011 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-organ failure | – | –Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to medical intensive care unit with severe sepsis or septic shock requiring mechanical ventilation.
Key inclusion criteria (2 listed)
- Adults with severe sepsis or septic shock on mechanical ventilation
- Enrolled in the initial six hours of ICU admission
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Mortality
Time frame: ICU mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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.
Rosa M Estrada-Y-Martin, MD MSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Severe Sepsis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa M Estrada-Y-Martin, MD MSc (713-500-6830, rosa.m.estrada.y.martin@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-organ failure (time frame: daily for 48 hours then weekly for 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.