ClinicalTrials.gg
Not yet recruitingNCT01315782Updated Jun 11, 2025

Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

An observational study in Sepsis, Severe Sepsis and Septic Shock, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Sepsis
  • Severe Sepsis
  • Septic Shock
  • Multi-organ Failure

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Keywords

  • Sepsis
  • Severe sepsis
  • Septic shock
  • Alveolar dead space
  • Multi-organ failure
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 30 is below the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with withdrawal or hospice order.
  • Patients with terminal, irreversible disease, expect to decease in 48 hours from ICU admission.
  • Patients with .
  • Patients transferred from outside ICU with ongoing sepsis management for more than six hours.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)

Groups and cohorts

  • Multi-organ failure

    Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: ICU mortality

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01315782
Responsible party
Rosa Estrada Y Martin (Associate Professor - IM, Critical Care, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Mar 15, 2011
Start date
Dec 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 11, 2025

Study contacts

Rosa M Estrada-Y-Martin, MD MSc
Contact
rosa.m.estrada.y.martin@uth.tmc.edu
713-500-6830
Rosa M Estrada-Y-Martin, MD MSc
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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