| Trial registration number
|
NCT04755972 |
Full text link
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04755972
|
First author
Last imported at : Feb. 15, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Nikola Delić, MD
|
Contact
Last imported at : Feb. 15, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
nkldelic@gmail.com
|
Registration date
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
2021-02-16
|
Recruitment status
Last imported at : Feb. 15, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- patients over 18 years of age with coronavirus pneumonia who need invasive mechanical
ventilation.
|
Exclusion criteria
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
- 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.
|
Number of arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
4
|
Funding
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Clinical Hospital Center, Split
|
Inclusion age min
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Croatia
|
Type of patients
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Critical disease at enrollment
|
Severity scale
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Feb. 15, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
175
|
primary outcome
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Difference between 4 arms regarding ventilator-associated pneumonia rate
|
Notes
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 612, "treatment_name": "Hypertonic saline", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1213, "treatment_name": "Sodium bicarbonate", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 18, "treatment_name": "Acetylcysteine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|