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

NCT04755972 | Completed

• 1 other identifier: 2181-147-01/06/M.S.-20-02
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; Pneumonia, Ventilator-Associated

Keywords

coronavirus disease 2019; Pneumonia, Ventilator-Associated; hypertonic saline; bicarbonate; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 6 months.

Secondary Outcomes (2)

• Number of ventilator-free days

  Day 28 after ICU admission.

• Mortality

  Day 28 after ICU admission.

Study Arms (4)

N-acetylcysteine

ACTIVE COMPARATOR

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

Other: Inhalation of N-acetylcysteine

Hypertonic saline

ACTIVE COMPARATOR

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

Other: Inhalation of 5% sodium chloride

Bicarbonate

ACTIVE COMPARATOR

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

Other: Inhalation of 8,4% sodium bicarbonate

Control group

NO INTERVENTION

No preventive inhalation.

Interventions

Inhalation of N-acetylcysteine OTHER

Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.

N-acetylcysteine

Inhalation of 5% sodium chloride OTHER

Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.

Hypertonic saline

Inhalation of 8,4% sodium bicarbonate OTHER

Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.

Bicarbonate

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Hospital Center, Split: lead

Study Sites (1)

Clinical Hospital Centre Split

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia, Ventilator-Associated; COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, intensive care specialist

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 16, 2021
• Study Start: October 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 29, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

CR (1)