Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Critically ill patients of age =18 years, getting CMS as part of their treatment based on suspected or confirmed infection caused by multidrug-resistant Gram-negative bacteria necessitating the administration of Colistin based on dosage regimens selected at the discretion of physicians. 2. Patient receiving intravenous Colistin with or without concomitant administration of Colistin through other routes (inhalational/intrathecal). Critically ill patients will be characterized by a state of poor health accompanied by dysfunction of vital organs, presenting a significant risk of impending death without immediate medical intervention, and with the possibility of recovery, as determined by the attending physician.
Exclusion criteria
Exclusion criteria: 1. No consent 2. Pregnancy or breastfeeding 3. Hypersensitivity to Colistin or Iohexol 4. Expected survival of less than 48 hours 5. Colistin administration within 1 week prior to enrolment. 6. Patients on drugs interacting with Iohexol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of ColistinTimepoint: 1.After loading dose of Colistin-1st day 2.After steady state of Colistin is achieved-after 9 infusions | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of covariates of significance for the establishment of population pharmacokinetic model. Iohexol Kel & AUC0-8, Plasma Iohexol clearanceTimepoint: Assess all the planned covariates at the start of study-Day 1. | — |
Countries
India
Contacts
Post Graduate Institute of Medical Education & Research, Chandigarh