Investigating the effect of diluent volume on colistin inhalation therapy for pneumonia
Effect of Diluent Volume on Colistin Inhalation Therapy for Mechanically Ventilated Respiratory Patients
NA · Fu Jen Catholic University · NCT06230614
This study is testing whether using different amounts of saline to dilute colistin can help improve treatment outcomes for patients on ventilators with pneumonia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fu Jen Catholic University (other) |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT06230614 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how different diluent volumes affect the clinical outcomes of colistin inhalation therapy in mechanically ventilated patients with inhalation pneumonia. It will compare two groups: one receiving colistin diluted in 6 ml of saline and the other in 12 ml. The study will assess various outcomes, including ICU length of stay, hospitalization duration, respiratory support duration, and mortality rates, while also analyzing the pharmacokinetics of colistin. The goal is to identify the optimal diluent volume for improving treatment efficacy in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are mechanically ventilated in the ICU and require inhalation colistin treatment.
Not a fit: Patients with renal failure requiring dialysis or those receiving both inhaled and intravenous colistin treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize colistin inhalation therapy, potentially improving recovery outcomes for critically ill patients with pneumonia.
How similar studies have performed: While the use of colistin for inhalation therapy is established, the specific investigation of diluent volume effects is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Taipei City
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Ke-Yun Chao, PhD — Fu Jen Catholic University Hospital
- Study coordinator: Ke-Yun Chao, PhD
- Email: C00152@mail.fjuh.fju.edu.tw
- Phone: +886-905-301-879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inhalation Pneumonia, Colistin, antibiotic, inhalation therapy, diluent volume, randomized controlled trial