Safety Study of Inhaled Saline in Acute Lung Injury

Pulmonary Edema Clinical Trial

Official title:

Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01713595
• Other study ID #: 12-001723
• Status: Withdrawn
• Phase: Phase 1
• First received: October 4, 2012
• Last updated: August 14, 2015
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).

Description:

Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study participants will include consenting adult patients (age > 18), who had been intubated and mechanically ventilated for <72 hours and meet international consensus criteria for ARDS.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Pulmonary Edema
• Respiratory Distress Syndrome, Adult

Intervention

Drug:
• Hypertonic Saline Aerosol
A single 5ml dose of 7% Saline aerosol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial Blood Gas Tension	Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.	Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery	Yes
Primary	Dynamic Compliance of the Respiratory System	Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema	Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery	Yes
Secondary	Patient-Ventilator Interactions	"Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy	5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery	Yes