Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
- Registration Number
- NCT05933642
- Lead Sponsor
- University of Malaya
- Brief Summary
The goal of this RCT is to compare the effectiveness of aminophylline and furosemide combination vs furosemide alone in producing effective diuresis in critically ill adults in ICU. ICU patients with the need of improved diuresis will be recruited and given either infusion of aminophylline and furosemide combination or furosemide alone, and their hourly urine output will be monitored to compare their effectiveness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period
- Oliguric patients, with the need for improved diuresis at clinician discretion - defined as urine output <0.5ml/kg/hour
- Patient refusal for participation of study
- Patients with known hypersensitivity reaction to aminophylline or furosemide
- Patients with history of tachyarrhythmias, seizures, aspartate aminotransferase or alanine aminotransferase > 3 times normal, or hypothyroidism.
Patient with existing peptic ulcer disease or coagulopathy with INR > 1.5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Aminophylline Intravenous (IV) infusion of (aminophylline 150mg and frusemide 120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour Treatment group Frusemide Intravenous (IV) infusion of (aminophylline 150mg and frusemide 120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour Control group Frusemide IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour
- Primary Outcome Measures
Name Time Method Percentage of patients with effective diuresis at 6 hours post intervention 6 hours post intervention whether effective diuresis is achieved at 6 hours post intervention. Effective diuresis is defined as urine output \>0.5ml/kg/hour based on patient's actual body weight
- Secondary Outcome Measures
Name Time Method Percentage of patients with effective diuresis at 2 hours post intervention 2 hours post intervention whether effective diuresis is achieved at 2 hours post intervention. Effective diuresis is defined as urine output \>0.5ml/kg/hour based on patient's actual body weight
Mean duration of infusion to achieve effective diuresis post intervention Up to 6 hours post interventions Time in hours taken for infusion to achieve effective diuresis post intervention. Effective diuresis is defined as urine output \>0.5ml/kg/hour based on patient's actual body weight
Changes in urine output at 6 hours post intervention 6 hours post interventions Difference of hourly urine output (ml/hour) measured immediately before starting intervention and 6 hours post intervention
Changes in serum creatinine at 1 day post intervention 1 day post intervention Difference of serum creatinine in mmol/l on the day of intervention and one day after intervention
Changes in serum eGFR at 1 day post intervention 1 day post intervention Difference of serum eGFR in mL/min/1.73m2 on the day of intervention and one day after intervention
Percentage of patients requiring Renal Replacement Therapy (RRT) throughout ICU stay, an average of 1 month Percentage of patients undergoing RRT during ICU stay
Trial Locations
- Locations (1)
University of Malaya
🇲🇾Kuala Lumpur, Malaysia