Effect of Diluent Volume on Colistin Inhalation Therapy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colistin 1 MU in normal saline 1 ml, Colistin 1 MU in normal saline 2 ml.
- Who it may be relevant to
- Registry conditions: Inhalation Pneumonia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Diluent Volume on Colistin Inhalation Therapy for Mechanically Ventilated Respiratory Patients
Overview
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.
Detailed description
Background： Colistin is an antibiotic used to treat infections caused by multidrug-resistant Gram-negative bacteria. In recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. Despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear.
Study Design： A single-center, prospective, randomized controlled trial.
Methods： The study plans to enroll 60 participants. Colistin inhalation therapy will be administered using a blocked stratified random allocation. The control group will receive colistin 6 MU diluted in 6 ml of normal saline (1 MU per 1 ml), while the experimental group will receive colistin 6 MU diluted in 12 ml of normal saline (1 MU per 2 ml). The dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 MU, administered every 8 hours, continuously for 7 days.
Effect： The investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. Based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.
Interventions
- Other Colistin 1 MU in normal saline 1 ml
Colistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml - Other Colistin 1 MU in normal saline 2 ml
Colistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
Primary outcome measures
- Drug concentration [Time frame: One hour post inhalation therapy with colistin on the third day of treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Renal failure requiring renal dialysis.
- Receiving both inhaled colistin and intravenous colistin treatments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Identifiers
NCT: NCT06230614 · FJUH112294