Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

NCT01315782 | Not Yet Recruiting

• 1 other identifier: HSC-MS-10-0555
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  daily for 48 hours then weekly for 2 weeks.

Secondary Outcomes (1)

• Mortality

  ICU mortality

Study Arms (1)

Multi-organ failure

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Rosa M Estrada-Y-Martin, MD MSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa M Estrada-Y-Martin, MD MSc

CONTACT

713-500-6830; rosa.m.estrada.y.martin@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - IM, Critical Care

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 15, 2011
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)