Effect of Diluent Volume on Colistin Inhalation Therapy
ConditionInhalation Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFu Jen Catholic University
About this trial
The aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. The study aims to determine whether the diluent volume has an effect on clinical outcomes, including ICU length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. Additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. The findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to the Intensive Care Unit.
Age greater than 18 years and using a ventilator due to acute respiratory failure.
Requires inhalation colistin treatment as determined by the disease.
Sign the written informed consent form.
Disqualifiers
Renal failure requiring renal dialysis.
Receiving both inhaled colistin and intravenous colistin treatments.
Trial design
Design model
Parallel
Treatments tested in this trial
Colistin 1 MU in normal saline 1 ml
Other interventionColistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml
Colistin 1 MU in normal saline 2 ml
Other interventionColistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Colistin 1 MU in normal saline 1 mlActive comparator 1 intervention
Group B: Colistin 1 MU in normal saline 2 mlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Drug concentration
Drug concentration in bronchoalveolar lavage fluid and blood
Time frame
One hour post inhalation therapy with colistin on the third day of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov