Effect of Diluent Volume on Colistin Inhalation Therapy
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedStudy Start
First participant enrolled
March 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
February 27, 2026
February 1, 2026
2.4 years
January 21, 2024
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drug concentration
Drug concentration in bronchoalveolar lavage fluid and blood
One hour post inhalation therapy with colistin on the third day of treatment
Study Arms (2)
Colistin 1 MU in normal saline 1 ml
ACTIVE COMPARATOR1 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 2 ml
EXPERIMENTAL1 MU of colistin in a total volume of 12 ml, diluted with a 1:2 ratio in normal saline (0.9%)
Interventions
Colistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml
Colistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Renal failure requiring renal dialysis.
- Receiving both inhaled colistin and intravenous colistin treatments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ke-Yun Chao, PhD
Fu Jen Catholic University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Group leader of Respiratory Therapists
Study Record Dates
First Submitted
January 21, 2024
First Posted
January 30, 2024
Study Start
March 10, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02