Effect of Diluent Volume on Colistin Inhalation Therapy
NCT ID: NCT06230614
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-10
2024-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Colistin 1 MU in normal saline 1 ml
1 MU of colistin in a total volume of 6 ml, diluted with a 1:1 ratio in normal saline (0.9%)
Colistin 1 MU in normal saline 1 ml
Colistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml
Colistin 1 MU in normal saline 2 ml
1 MU of colistin in a total volume of 12 ml, diluted with a 1:2 ratio in normal saline (0.9%)
Colistin 1 MU in normal saline 2 ml
Colistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
Interventions
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Colistin 1 MU in normal saline 1 ml
Colistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml
Colistin 1 MU in normal saline 2 ml
Colistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
Eligibility Criteria
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Inclusion Criteria
* 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
* Receiving both inhaled colistin and intravenous colistin treatments.
18 Years
100 Years
ALL
No
Sponsors
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Fu Jen Catholic University
OTHER
Responsible Party
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Ke-Yun, Chao
Group leader of Respiratory Therapists
Principal Investigators
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Ke-Yun Chao, PhD
Role: PRINCIPAL_INVESTIGATOR
Fu Jen Catholic University Hospital
Locations
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Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FJUH112294
Identifier Type: -
Identifier Source: org_study_id
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