| CTRI Number |
CTRI/2024/12/077762 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how the drug Colistin is processed in the bodies of very sick patients. |
|
Scientific Title of Study
|
A prospective, non-randomized Population Pharmacokinetic study of Colistin in critically ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samir Malhotra |
| Designation |
Professor and Head, Department of Pharmacology |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Room Number 4001, Department of Pharmacology, PN Chuttani
Block, Post Graduate Institute of Medical Education & Research
(PGIMER), Sector-12,
Chandigarh
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755254 |
| Fax |
|
| Email |
smal.pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir Malhotra |
| Designation |
Professor and Head, Department of Pharmacology |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Room Number 4001, Department of Pharmacology, PN Chuttani
Block, Post Graduate Institute of Medical Education & Research
(PGIMER), Sector-12,
Chandigarh
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755254 |
| Fax |
|
| Email |
smal.pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aayudhin Menon P |
| Designation |
Resident |
| Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| Address |
Room Number 4019, Department of Pharmacology, PN Chuttani
Block, Post Graduate Institute of Medical Education & Research
(PGIMER), Sector-12,
Chandigarh
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7306529469 |
| Fax |
|
| Email |
draayudhinmenon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pharmacology,PGIMER,Chandigarh-160012,India |
|
|
Primary Sponsor
|
| Name |
Post graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Sector 12, Chandigarh-160012, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAayudhin Menon |
PGIMER |
ICU,Nehru hospital,PGIMER,Chandigarh-160012
Chandigarh
CHANDIGARH |
7306529469
draayudhinmenon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iohexol |
Involves taking blood samples after Iohexol administration to determine Iohexol clearance and GFR estimation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic parameters of Colistin |
1.After loading dose of Colistin-1st day
2.After steady state of Colistin is achieved-after 9 infusions
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of covariates of significance for the establishment of population pharmacokinetic model.
Iohexol Kel & AUC0-∞, Plasma Iohexol clearance |
Assess all the planned covariates at the start of study-Day 1. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.Screen critically ill patients admitted in ICU 2.Obtain consent if eligible. 3.Obtain the demographic details, baseline investigation results, primary diagnosis, medication history, etc 4.Estimate GFR using various formulas. 5.Obtain 24 hour urine sample for urinary creatinine clearance calculation. 6.Administer 5 mL of Iohexol IV bolus, obtain 4 blood samples of 2 mL each at 2,4,8 and 12 hour after administration to calculate GFR by iohexol plasma clearance method. 7.Collect 4 venous blood samples of 2 mL each after 2 h,8h,12h and between 18-24 hour after the administration of loading dose of colistin. 8.Collect 3 blood samples of 2 mL each after the steady state of colistin has been achieved at 1 h, 8 h and and 12 h of maintenance dose administration. 9.Analyse the date after getting the pharmacokinetic parameters of Colistin. 10.Prepare a population pharamacokinetic model including the significant covariates for Colistin dosing in critically ill patients. |