Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults

Study Overview
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Brief Summary
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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.

Official Title
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Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Aminophylline
* Drug: Frusemide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind, randomised, controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>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 | Drug: Aminophylline<br>* aminophylline 150mg<br>Drug: Frusemide<br>* frusemide 120mg<br>* Other names: Lasix;|
| Active Comparator: Control group<br>IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour | Drug: Frusemide<br>* frusemide 120mg<br>* Other names: Lasix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with effective diuresis at 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 | 6 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with effective diuresis at 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 | 2 hours post intervention | 
| Mean duration of infusion to achieve effective diuresis post intervention | 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 | Up to 6 hours post interventions | 
| Changes in urine output at 6 hours post intervention | Difference of hourly urine output (ml/hour) measured immediately before starting intervention and 6 hours post intervention | 6 hours post interventions | 
| Changes in serum creatinine at 1 day post intervention | Difference of serum creatinine in mmol/l on the day of intervention and one day after intervention | 1 day post intervention | 
| Changes in serum eGFR at 1 day post intervention | Difference of serum eGFR in mL/min/1.73m2 on the day of intervention and one day after intervention | 1 day post intervention | 
| Percentage of patients requiring Renal Replacement Therapy (RRT) | Percentage of patients undergoing RRT during ICU stay | throughout ICU stay, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)