N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome

NCT03346681 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: PalmettoHealth
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Ventilator days

  Number of days requiring mechanical ventilation

  From time of intubation until one of predefined endpoints (up to 60 days)

Secondary Outcomes (4)

• Mortality

  up to 60 days

• ICU days

  From time of admission to the ICU until transfer out of the unit (up to 60 days)

• P/F ratio

  Daily until the predefined endpoints (up to 60 days)

• Use of "rescue" maneuvers

  Daily until the predefined endpoints (up to 60 days)

Study Arms (2)

NAC and albuterol

EXPERIMENTAL

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

Albuterol

NO INTERVENTION

Albuterol will be administered via nebulization every six hours.

Interventions

N-acetyl cysteine DRUG

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.).

NAC and albuterol

Eligibility Criteria

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

Sponsors & Collaborators

• Prisma Health-Midlands: lead

Study Sites (1)

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Judson Lewis, MD

  Prisma Health-Midlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients meeting inclusion criteria will be randomly assigned to the treatment or control group

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2018
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)