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CTRI Number  CTRI/2024/07/069831 [Registered on: 02/07/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Optimization of antimicrobial therapy based on average creatinine-urea clearance in critically ill patients - A Pilot study 
Scientific Title of Study   An open-label, randomized, pragmatic clinical trial comparing the current clinical practices to pharmacologist guided optimization of antimicrobial therapy based on average creatinine-urea clearance in critically ill patients - A Pilot study  
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 Sanjeev Khanth P E 
Designation  Senior resident 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Gate 5, Medical college building, Room 2205, 2nd floor, Department of Pharmacology, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8130464536  
Fax    
Email  sanjeev199521@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin R Gaikwad 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Pharmacology, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8518881725  
Fax    
Email  nitingaikwad2707@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitin R Gaikwad 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Pharmacology, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8518881725  
Fax    
Email  nitingaikwad2707@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raipur 
Address  All India Institute Of Medical Sciences, Raipur Tatibandh, G E Road, Raipur Chhattisgarh. Pin No 492 099 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Khanth P E  All India Institute of Medical Sciences, Raipur  A-Block,2nd Floor,Critical care unit, Department of Anesthesiology and critical care, All India Institute of Medical Sciences, Raipur Tatibandh 492099
Raipur
CHHATTISGARH 		 8130464536

sanjeev199521@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (3) ICD-10 Condition: N17||Acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Optimization of the antimicrobial therapy using average urine creatinine-urea clearance   7 days from the date of admission to the unit  
Comparator Agent  Optimization of the antimicrobial therapy using eGFR  7 days from the date of admission to the unit 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age 18-75 both sexes
Patients admitted to the critical care unit (CCU)
Expected to stay more than 24 hours in CCU
Receiving at least one antimicrobial agent having renal clearance
Patient randomized to the intervention arm giving consent to collect 8-hour urine for average creatinine-urea clearance estimation
 
 
ExclusionCriteria 
Details  Chronic Kidney disease (CKD)
AKI on CKD
Patient not on renal replacement therapy at the time of enrollment
Clinical suspicion for Rhabdomyolysis
Pregnancy or breastfeeding.
Patients enrolled in other interventional clinical trials simultaneously

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in SOFA score from baseline (delta SOFA score)  baseline, day 3, and day 7  
 
Secondary Outcome  
Outcome  TimePoints 
Number of events of optimization of antimicrobial therapy  Period of ICU stay 
Length of ICU stay   day of ICU admission to day of discharge/transfer out/death 
28-day all cause in-hospital mortality   Day 28 
Antimicrobial consumption rate  period of ICU stay 
Acceptance rate of recommendations given for optimization of antimicrobial therapy  Day 1 to Day 7 
Clostridium difficile infection rate  period of ICU stay 
Ventilator free days  Period of ICU stay 
Switch of parenteral to oral route  Period of ICU stay 
ARCTIC score   Period of ICU stay 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 30/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Antimicrobial therapy plays essential role in the management of patients admitted in the critical care unit. There is a considerable variation in the hemodynamics of critically ill patients. They may experience acute kidney injury or augmented renal clearance during their course of stay. This hemodynamic instability affects the pharmacokinetics of the administered antimicrobial agents which are primarily exhibit renal elimination. This leads to unstable therapeutic concentration which can result in therapeutic failure or toxicity leading to adverse reactions. Dose adjustment is usually done by calculating estimated glomerular filtration rate (eGFR) which is often unreliable in critically ill patients. Calculating the GFR using average of urine urea and creatinine clearance and optimizing dose according to this is found superior to eGFR in various studies. Our hypothesis is ’What is the effectiveness of Pharmacologist guided optimization of antimicrobial therapy based on average creatinine-urea clearance on clinical outcomes in critically ill patient admitted in critical care unit ?’. Therefore, our aim is to evaluate the effectiveness of average creatinine-urea clearance in optimization of antimicrobial therapy in critically ill patients admitted in Critical care unit.  
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