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

University of Malaya

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Acute Kidney Injury

Treatments: Drug: Aminophylline; Drug: Frusemide

Study type: Interventional

Funder types: Other

Identifiers

NCT05933642

202334-12198

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

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:

Drug: Frusemide

Drug: Aminophylline

Control group

Active Comparator group

Description:

IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour

Treatment:

Drug: Frusemide