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

Sponsor

University of Malaya (Other)

Overall Status

Recruiting

CT.gov ID

NCT05933642

Collaborator

(none)

132

Enrollment

Location

Arms

Anticipated Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Aminophylline Drug: Frusemide	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind, randomised, controlled trialdouble blind, randomised, controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 2, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of patients with effective diuresis at 6 hours post intervention [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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