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: Recruiting
• Conditions: Sepsis; Septic Shock; Severe Sepsis; Multi-organ Failure

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: Observational
• Enrollment (Estimated): 30

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

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital
      • 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: 18 years and older (Adult, Older Adult)
• 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.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Multi-organ failure; Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All the patient will be followed up to 28-days to determine survival.	ICU mortality

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• 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 (Actual): December 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimated): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Septic shock; Sepsis; Severe sepsis; Alveolar dead space; Multi-organ failure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Shock, Septic; Multiple Organ Failure
• Other Study ID Numbers: HSC-MS-10-0555