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Optimization of antimicrobial therapy based on average creatinine-urea clearance in critically ill patients - A Pilot 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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069831
Enrollment
60
Registered
2024-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: N17- Acute kidney failure Health Condition 2: A00-B99- Certain infectious and parasitic diseases Health Condition 3: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Optimization of the antimicrobial therapy using average urine creatinine-urea clearance: 7 days from the date of admission to the unit Control Intervention1: Optimization of the antimic

Sponsors

All India Institute of Medical Sciences, Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change in SOFA score from baseline (delta SOFA score)Timepoint: baseline, day 3, and day 7—

Secondary

MeasureTime frame
28-day all cause in-hospital mortalityTimepoint: Day 28;Acceptance rate of recommendations given for optimization of antimicrobial therapyTimepoint: Day 1 to Day 7;Antimicrobial consumption rateTimepoint: period of ICU stay;ARCTIC scoreTimepoint: Period of ICU stay;Clostridium difficile infection rateTimepoint: period of ICU stay;Length of ICU stayTimepoint: day of ICU admission to day of discharge/transfer out/death;Number of events of optimization of antimicrobial therapyTimepoint: Period of ICU stay;Switch of parenteral to oral routeTimepoint: Period of ICU stay;Ventilator free daysTimepoint: Period of ICU stay—

Countries

India

Contacts

Public ContactDr Nitin R Gaikwad

All India Institute of Medical Sciences, Raipur

nitingaikwad2707@aiimsraipur.edu.in8518881725

Outcome results

None listed

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