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

NCT ID: NCT05933642

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-02

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind, randomised, controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Aminophylline

Intervention Type DRUG

aminophylline 150mg

Frusemide

Intervention Type DRUG

frusemide 120mg

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

Group Type ACTIVE_COMPARATOR

Frusemide

Intervention Type DRUG

frusemide 120mg

Interventions

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Aminophylline

aminophylline 150mg

Intervention Type DRUG

Frusemide

frusemide 120mg

Intervention Type DRUG

Other Intervention Names

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Lasix

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Dr Ng Haw Shyan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haw Shyan Ng

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University of Malaya

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Haw Shyan Ng

Role: CONTACT

+6 016 483 7722

Facility Contacts

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Haw Shyan Ng, MBBS

Role: primary

0164837722

Other Identifiers

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202334-12198

Identifier Type: -

Identifier Source: org_study_id

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