Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

Sepsis Clinical Trial

Official title:

Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315782
• Other study ID #: HSC-MS-10-0555
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Rosa M Estrada-Y-Martin, MD MSc
• Phone: 713-500-6830
• Email: rosa.m.estrada.y.martin[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multi-organ Failure
• Multiple Organ Failure
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	All the patient will be followed up to 28-days to determine survival.	ICU mortality