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Trial record 17 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome (NARDS)

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ClinicalTrials.gov Identifier: NCT03346681
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Midlands

Brief Summary:
We would study whether there is any measurable benefit of the administration of nebulized n-acetyl-cysteine to acute respiratory distress syndrome patients starting within 48 hours of intubation and mechanical ventilation.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: N-acetyl cysteine Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients meeting inclusion criteria will be randomly assigned to the treatment or control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: NAC and albuterol
The procedure involved would be the administration of N-acetylcysteine via nebulization, which would be administered to the patient by respiratory therapy in the dosage of 2 mL 20% solution acetylcysteine (or 4 mL of 10% solution) along with inhaled albuterol via endotracheal tube every six hours for 72 hours total. The control arm will have saline administered with the albuterol every six hours. Both arms will have additional bronchodilators administered as indicated clinically (bronchospasm, COPD, peak airway pressure elevation, etc.).
Drug: N-acetyl cysteine
The procedure involved would be the administration of N-acetylcysteine via nebulization, which would be administered to the patient by respiratory therapy in the dosage of 2 mL 20% solution acetylcysteine (or 4 mL of 10% solution) along with inhaled albuterol via endotracheal tube every six hours for 72 hours total. The control arm will have saline administered with the albuterol every six hours. Both arms will have additional bronchodilators administered as indicated clinically (bronchospasm, COPD, peak airway pressure elevation, etc.).

No Intervention: Albuterol
Albuterol will be administered via nebulization every six hours.



Primary Outcome Measures :
  1. Ventilator days [ Time Frame: From time of intubation until one of predefined endpoints (up to 60 days) ]
    Number of days requiring mechanical ventilation


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 60 days ]
    Number of days until expiring

  2. ICU days [ Time Frame: From time of admission to the ICU until transfer out of the unit (up to 60 days) ]
    Number of days in the ICU

  3. P/F ratio [ Time Frame: Daily until the predefined endpoints (up to 60 days) ]
    A measure of the partial pressure of oxygen divided by the percentage of inhaled oxygen

  4. Use of "rescue" maneuvers [ Time Frame: Daily until the predefined endpoints (up to 60 days) ]
    Using airway pressure release ventilation, paralytics, or proning



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria includes adult patients admitted to the medical intensive care unit or coronary care unit, being mechanically ventilated with a positive end expiratory pressure greater than 5 cm H2O, with noncardiogenic pulmonary edema on chest x-ray within 48 hours of being noted to have a P/F ratio < 150.

Exclusion Criteria:

  • Exclusion criteria includes patients < 18 years of age, patients for whom no aggressive measures are desired, patients who are already receiving "rescue methods" (prone positioning, advanced ventilator modes, paralytics), trauma patients, vulnerable patient groups (pregnant, prisoners), patients who have undergone a surgical operation during their time on the ventilator, patients with end stage liver disease, patients on chronic ventilators, and asthmatics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346681


Contacts
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Contact: Judson Lewis, MD 7063064910 drjudlewis@gmail.com

Locations
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United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Judson Lewis, MD    706-306-4910    phathands@hotmail.com   
Contact: Rohan Arya, MD    4074355389    rohan.arya@uscmed.sc.edu   
Sponsors and Collaborators
Prisma Health-Midlands
Investigators
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Principal Investigator: Judson Lewis, MD Prisma Health-Midlands

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Responsible Party: Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT03346681     History of Changes
Other Study ID Numbers: PalmettoHealth
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Acetylcysteine
Albuterol
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Tocolytic Agents
Reproductive Control Agents