Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346681
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : November 17, 2017
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Midlands

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
Ventilator days [ Time Frame: From time of intubation until one of predefined endpoints (up to 60 days) ]
Number of days requiring mechanical ventilation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Mortality [ Time Frame: up to 60 days ]
    Number of days until expiring
  • 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
  • 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
  • Use of "rescue" maneuvers [ Time Frame: Daily until the predefined endpoints (up to 60 days) ]
    Using airway pressure release ventilation, paralytics, or proning
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome
Official Title  ICMJE N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome
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.
Detailed Description

Objectives / Research Aims The overall objectives of this study are to demonstrate whether a protocol for the early use of inhaled N-acetylcysteine improves mortality, ventilator days, ICU days, hospital stay, as well as the need for other "rescue" modalities, such as use of advanced ventilator modalities (such as airway pressure release ventilation [APRV]), paralytics, and prone positioning. As this is a pilot study, we would address the feasibility of recruiting and consenting patients as well as to ascertain the sample size that would be needed to power the desired endpoints in a larger study.

Setting The project will be performed in the Medical Intensive Care Unit at Palmetto Health Richland using subjects with severe acute respiratory distress syndrome that are identified within 48 hours of their disease process.

Resources Available It is not uncommon for the patients admitted with or that develop acute respiratory distress syndrome to receive breathing treatments of some variety, such as bronchodilators. This study would take an existing practice and add a relatively inexpensive medication, N-acetylcysteine.

It will be straightforward and require relatively little time to calculate the metrics for the patients enrolled in this study as these data are typically collected for intensive care unit patients already.

Our respiratory therapists are already very experienced and proficient at the administration of inhaled N-acetylcysteine. Likewise, the academic intensive care team would be able to readily classify the patients that are appropriate for this study as the partial pressure of oxygen to fraction of inspired oxygen (P/F) ratio is typically documented for every ventilated patient admitted to our unit.

Study Design Recruitment Methods The patients will be recruited based upon their P/F ratio less than 150 and being mechanically ventilated with a positive end expiratory pressure of 5 or greater. These patients will be started on the protocol within 48 hours of developing acute respiratory distress syndrome.

Inclusion and Exclusion 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 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.

Local Number of Subjects This study will seek to enroll 26 patients each in the treatment and control arm.

Study-Wide Number of Subjects This is a single center study. Study Timelines Plans will be to complete the study within 12 months from the time of start. Study Endpoints The patient is liberated from the ventilator, discharged from the ICU, discharged from the hospital, or dies.

Procedures Involved The only 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 3 2 mL 20% solution acetylcysteine (or 6 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.).

The patients would be monitored daily in the ICU setting with lab work, including arterial blood gases, chemistry panels, complete blood counts. They would have all routine critical care monitoring, such as hourly vital signs, urine output, ventilation parameters in accordance with the nature of their critical illness.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE 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.).
Study Arms  ICMJE
  • 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.).
    Intervention: Drug: N-acetyl cysteine
  • No Intervention: Albuterol
    Albuterol will be administered via nebulization every six hours.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 25, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2017)
52
Actual Study Completion Date  ICMJE January 30, 2021
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03346681
Other Study ID Numbers  ICMJE PalmettoHealth
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prisma Health-Midlands
Study Sponsor  ICMJE Prisma Health-Midlands
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judson Lewis, MD Prisma Health-Midlands
PRS Account Prisma Health-Midlands
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP