NCT00131521

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

First QC Date

August 17, 2005

Last Update Submit

June 20, 2009

Conditions

Mucus ObstructionIntubation

Keywords

mucus obstruction, ventilator management

Outcome Measures

Primary Outcomes (1)

  • prevention of pulmonary mucus obstruction

Secondary Outcomes (1)

  • days of mechanical ventilation

Interventions

mucomystDRUG
sodium chloride (saline)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

AcetylcysteineSodium Chloride

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • John G. Myers, M.D.

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 18, 2005

Study Start

January 1, 2005

Study Completion

December 1, 2007

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

US(1)