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

NCT05933642 | Unknown Phase 2

• 1 other identifier: 202334-12198
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Aminophylline; Furosemide; Critically ill; Adults; Intensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of patients with effective diuresis at 2 hours post intervention

  2 hours post intervention

• Mean duration of infusion to achieve effective diuresis post intervention

  Up to 6 hours post interventions

• Changes in urine output at 6 hours post intervention

  6 hours post interventions

• Changes in serum creatinine at 1 day post intervention

  1 day post intervention

• Changes in serum eGFR at 1 day post intervention

  1 day post intervention

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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; Drug: Frusemide

Control group

ACTIVE COMPARATOR

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

Interventions

Aminophylline DRUG

aminophylline 150mg

Treatment group

Frusemide DRUG

frusemide 120mg

Also known as: Lasix

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Interventions

Aminophylline; Furosemide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Sulfones; Sulfur Compounds

Study Officials

• Haw Shyan Ng

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haw Shyan Ng

CONTACT

+6 016 483 7722; plue_chris@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Recruited patient randomised into intervention vs control group by non clinical personnel, trial drugs dilution by research assistant, drug administered to patient by staff nurses, data collection by independent group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double blind, randomised, controlled trial

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 6, 2023
• Study Start: July 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)