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A study on how the drug Colistin is processed in the bodies of very sick patients.

A prospective, non-randomized Population Pharmacokinetic study of Colistin in critically ill patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077762
Enrollment
30
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Iohexol: Involves taking blood samples after Iohexol administration to determine Iohexol clearance and GFR estimation.

Sponsors

Post graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Aayudhin Menon P

Post Graduate Institute of Medical Education & Research, Chandigarh

smal.pgi@gmail.com01722755254

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026