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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Aminophylline; Drug: Frusemide

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Haw Shyan Ng; Phone Number: +6 016 483 7722; Email: plue_chris@yahoo.co.uk

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • Recruiting
    • University of Malaya
    • Contact: Haw Shyan Ng, MBBS; Phone Number: 0164837722; Email: plue_chris@yahoo.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group; 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; aminophylline 150mg; Drug: Frusemide; frusemide 120mg; Other Names: Lasix
Active Comparator: Control group; 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; frusemide 120mg; Other Names: Lasix

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Haw Shyan Ng, University of Malaya

Study record dates

Study Major Dates

• Study Start (Estimated): July 2, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adults; Furosemide; Critically ill; Aminophylline; Intensive Care Unit (ICU)
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Critical Illness; Acute Kidney Injury; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Protective Agents; Natriuretic Agents; Cardiotonic Agents; Membrane Transport Modulators; Diuretics; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Sodium Potassium Chloride Symporter Inhibitors; Aminophylline; Furosemide
• Other Study ID Numbers: 202334-12198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No