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Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

Primary Purpose

Corona Virus Infection, Pneumonia, Ventilator-Associated

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Inhalation of N-acetylcysteine
Inhalation of 5% sodium chloride
Inhalation of 8,4% sodium bicarbonate
Sponsored by
Clinical Hospital Center, Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corona Virus Infection focused on measuring coronavirus disease 2019, Pneumonia, Ventilator-Associated, hypertonic saline, bicarbonate, N-acetylcysteine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation.

Exclusion Criteria:

  • Patients with polytrauma,
  • pregnant women,
  • severe hemodynamic instability,
  • patients with pulmonary edema,
  • less than 3 days spent in the ICU,
  • patients who have microbiologically proven bacterial infection on arrival.

Sites / Locations

  • Clinical Hospital Centre Split

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

N-acetylcysteine

Hypertonic saline

Bicarbonate

Control group

Arm Description

Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.

Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.

Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.

No preventive inhalation.

Outcomes

Primary Outcome Measures

Difference between 4 arms regarding ventilator-associated pneumonia rate
Patients will be monitored for ventilator-associated pneumonia according to clinical criteria with a new or progressive pulmonary infiltrate on imaging plus supportive clinical findings of infection (eg, fever, secretions, leukocytosis). The diagnosis is confirmed when lower respiratory tract sampling identifies a pathogen.

Secondary Outcome Measures

Number of ventilator-free days
Number of days from day 1 after ICU admission and start of mechanical ventilation on which a patient breathes without assistance of the ventilator if the period of unassisted breathing lasted at least 24 consecutive hours.
Mortality
Life status (alive or deceased) on day 28 after ICU admission.

Full Information

First Posted
February 6, 2021
Last Updated
February 11, 2022
Sponsor
Clinical Hospital Center, Split
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1. Study Identification

Unique Protocol Identification Number
NCT04755972
Brief Title
Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
Official Title
Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Center, Split

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
It is planned to include patients over 18 years of age of both sexes, admitted to the Intensive Care Unit of Clinical Hospital Centre Split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation. The patients will be divided into four groups. Group 1 will receive N-acetylcysteine inhalation, Group 2 will receive inhalation with a 5% sodium chloride solution, and Group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively. All inhalations will be given twice a day 12 hours apart. The first inhalation will be included within 12 hours of the patient being enrolled in the Intensive Care Unit. Patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol. RESEARCH GOALS The aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (VAP) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients. Hypothesis Coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with N-acetylcysteine, 5% saline, or patients without preventive inhalation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection, Pneumonia, Ventilator-Associated
Keywords
coronavirus disease 2019, Pneumonia, Ventilator-Associated, hypertonic saline, bicarbonate, N-acetylcysteine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
Inhalation of 5 ml-s of N-acetylcysteine every 12 hours.
Arm Title
Hypertonic saline
Arm Type
Active Comparator
Arm Description
Inhalation of 5 ml-s of 5% sodium chloride every 12 hours.
Arm Title
Bicarbonate
Arm Type
Active Comparator
Arm Description
Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No preventive inhalation.
Intervention Type
Other
Intervention Name(s)
Inhalation of N-acetylcysteine
Intervention Description
Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
Inhalation of 5% sodium chloride
Intervention Description
Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
Inhalation of 8,4% sodium bicarbonate
Intervention Description
Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.
Primary Outcome Measure Information:
Title
Difference between 4 arms regarding ventilator-associated pneumonia rate
Description
Patients will be monitored for ventilator-associated pneumonia according to clinical criteria with a new or progressive pulmonary infiltrate on imaging plus supportive clinical findings of infection (eg, fever, secretions, leukocytosis). The diagnosis is confirmed when lower respiratory tract sampling identifies a pathogen.
Time Frame
Through study completion, an average of 6 months.
Secondary Outcome Measure Information:
Title
Number of ventilator-free days
Description
Number of days from day 1 after ICU admission and start of mechanical ventilation on which a patient breathes without assistance of the ventilator if the period of unassisted breathing lasted at least 24 consecutive hours.
Time Frame
Day 28 after ICU admission.
Title
Mortality
Description
Life status (alive or deceased) on day 28 after ICU admission.
Time Frame
Day 28 after ICU admission.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation. Exclusion Criteria: Patients with polytrauma, pregnant women, severe hemodynamic instability, patients with pulmonary edema, less than 3 days spent in the ICU, patients who have microbiologically proven bacterial infection on arrival.
Facility Information:
Facility Name
Clinical Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

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