Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury

NCT01667666 | Terminated Phase 1 DMC

• 1 other identifier: COMIRB #11-0706
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.

Conditions

Acute Lung Injury; Adult Respiratory Distress Syndrome

Keywords

trauma; acute lung injury; adult respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• change in the respiratory parameters

  For intubated patients - A decrease greater than 20% in PaO2/FiO2 (P/F) ratios will trigger DSMB review. For not intubated patients - a) the need to increase FiO2 by 10% (approximate 4 liter/minute increase) to maintain a peripheral oxygen saturation (SaO2) of 90% during nebulizer treatment; b) evidence of respiratory distress (as documented in the chart by the patient's attending) during nebulizer treatment; and c) respiratory insufficiency requiring intubation and mechanical ventilation at any point will trigger DSMB review.

  baseline and every 6 hours for 36 hours

Secondary Outcomes (4)

• death within 28 days

  28 days or discharge

• lung dysfunction scores

  baseline and 28 days or discharge

• ventilator-free days (VFD)

  baseline and 28 days or discharge

• MOF scores (Denver MOF score)

  28 days or discharge

Study Arms (1)

Nebulized HTS

EXPERIMENTAL

The first 5 patients will receive 3% Nebulized hypertonic saline, the second 5 patients will receive 4.5% Nebulized hypertonic saline, the third group 6% Nebulized hypertonic saline, and the fourth group of 5 patients will receive 7% Nebulized hypertonic saline. The nebulizer is dosed 2-3 times a day for 36 hours.

Drug: Nebulized hypertonic saline

Interventions

Nebulized hypertonic saline DRUG

The first 5 patients will receive 3% hypertonic saline in a nebulizer, the second 5 patients will receive 4.5% nebulized hypertonic saline, the third group 6% nebulized hypertonic saline, and the fourth group of 5 patients will receive 7% nebulized hypertonic saline. The nebulizer is dosed 2-3 times a day for 36 hours.

Nebulized HTS

Eligibility Criteria

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

You may qualify if:

• adult 18 ≤ age ≤ 65
• trauma with a 9 ≤ NISS ≤ 36
• ≤10 units of RBC in the first 6 hours (as this is a major risk factor for ARDS and MOF in this population)

You may not qualify if:

• Direct or indirect lung injury
• Elevated intracranial pressure requiring treatment, including but not limited to mannitol, intravenous hypertonic saline, and ventricular drainage
• History of severe chronic respiratory disease
• Child-Pugh Class C liver failure
• Prisoners
• Pregnant women

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ernest E Moore, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 17, 2012
• Study Start: May 1, 2012
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

US (1)