NCT01713595

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

October 4, 2012

Last Update Submit

August 14, 2015

Conditions

Pulmonary Edema

Keywords

Acute Lung InjuryMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient-Ventilator Interactions

    5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery

Other Outcomes (1)

  • Arterial Blood Gas Tension

    Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery

Study Arms (1)

Hypertonic Saline Aerosol

EXPERIMENTAL

a single 5ml dose of 7% Saline aerosol

Drug: Hypertonic Saline Aerosol

Interventions

Hypertonic Saline AerosolDRUG

A single 5ml dose of 7% Saline aerosol

Also known as: Nebulized hypertonic saline
Hypertonic Saline Aerosol

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary EdemaAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung Injury

Study Officials

  • Richard A Oeckler, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine and Physiology

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 25, 2012

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-08