Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit

This study has been completed.

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00131521

Purpose

This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).

Condition	Intervention
Mucus Obstruction Intubation	Drug: mucomyst Drug: sodium chloride (saline)

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Acetylcysteine Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit: A Randomized, Double Blind, Controlled Trial

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

prevention of pulmonary mucus obstruction

Secondary Outcome Measures:

days of mechanical ventilation

Estimated Enrollment:	260
Study Start Date:	January 2005
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Intubated and admitted to the Surgical Trauma Intensive Care Unit (STICU)
Subjects must be eligible to start treatment within 24 hours of their initial intubation

Exclusion Criteria:

Patient anticipated to be extubated within 24 hours following STICU admission
Hypersensitivity to acetylcysteine.
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131521

Locations

United States, Texas
Univesity Hospital
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator:

John G. Myers, M.D.

University of Texas Health Science Center San Antonio

More Information

Study ID Numbers:	034-1502-320
Study First Received:	August 17, 2005
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00131521
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

mucus obstruction, ventilator management

Study placed in the following topic categories:

Wounds and Injuries
Acetylcysteine
N-monoacetylcystine

ClinicalTrials.gov processed this record on January 16, 2009