Corona Virus InfectionNCT04755972
Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
A study testing Inhalation of N-acetylcysteine, Inhalation of 5% sodium chloride and Inhalation of 8,4% sodium bicarbonate in people with Corona Virus Infection and Pneumonia, Ventilator-Associated, run by Clinical Hospital Center, Split at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Pneumonia, Ventilator-Associated
- What is being tested?
- Inhalation of N-acetylcysteine, Inhalation of 5% sodium chloride and Inhalation of 8,4% sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2020to 29 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
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.
Read more
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.
- Being tested
- Inhalation of N-acetylcysteine, Inhalation of 5% sodium chloride, Inhalation of 8,4% sodium bicarbonate
- Keywords
- coronavirus disease 2019, Pneumonia, Ventilator-Associated, hypertonic saline, bicarbonate, N-acetylcysteine
- Medical subject headings
- Coronavirus Infections, Pneumonia, Ventilator-Associated, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation of N-acetylcysteineOther
Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
Inhalation of 5% sodium chlorideOther
Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.
Inhalation of 8,4% sodium bicarbonateOther
Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | Inhalation of 5 ml-s of N-acetylcysteine every 12 hours. Receives: Other: Inhalation of N-acetylcysteine |
| Hypertonic saline | Active comparator | Inhalation of 5 ml-s of 5% sodium chloride every 12 hours. Receives: Other: Inhalation of 5% sodium chloride |
| Bicarbonate | Active comparator | Inhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours. Receives: Other: Inhalation of 8,4% sodium bicarbonate |
| Control group | No intervention | No preventive inhalation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (2)
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.
Measured: Day 28 after ICU admission.
Mortality
Life status (alive or deceased) on day 28 after ICU admission.
Measured: Day 28 after ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Oct 2020
- Primary completion1 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center, Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Delić, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755972
- Sponsor's protocol ID
- 2181-147-01/06/M.S.-20-02
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2
- ClinicalTrials.gov ID
- NCT04755972
- Acronym / sponsor ID
- 2181-147-01/06/M.S.-20-02
- Keywords
- coronavirus disease 2019, Pneumonia, Ventilator-Associated, hypertonic saline, bicarbonate, N-acetylcysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Clinical Hospital Center, SplitUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Other: Inhalation of N-acetylcysteineInhalation of 5 ml-s of N-acetylcysteine every 12 hours. |
| Hypertonic saline | Active comparator | Other: Inhalation of 5% sodium chlorideInhalation of 5 ml-s of 5% sodium chloride every 12 hours. |
| Bicarbonate | Active comparator | Other: Inhalation of 8,4% sodium bicarbonateInhalation of 5 ml-s 8.4% sodium bicarbonate every 12 hours. |
| Control group | No intervention | –No preventive inhalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation.
Key exclusion criteria (6 listed)
- Patients with polytrauma,
- pregnant women,
- severe hemodynamic instability,
- patients with pulmonary edema,
- less than 3 days spent in the ICU,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation of N-acetylcysteineGroup 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation. | Other | N-acetylcysteine |
| Inhalation of 5% sodium chlorideGroup 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation. | Other | Hypertonic saline |
| Inhalation of 8,4% sodium bicarbonateGroup 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation. | Other | Bicarbonate |
Primary outcome
Difference between 4 arms regarding ventilator-associated pneumonia rate
Time frame: Through study completion, an average of 6 months.
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.
2 secondary outcomes
Number of ventilator-free days
Time frame: Day 28 after ICU admission.
Mortality
Time frame: Day 28 after ICU admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Corona Virus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation of N-acetylcysteine, Inhalation of 5% sodium chloride and Inhalation of 8,4% sodium bicarbonate in people with Corona Virus Infection and Pneumonia, Ventilator-Associated, run by Clinical Hospital Center, Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between 4 arms regarding ventilator-associated pneumonia rate (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.