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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933642
• Other study ID #: 202334-12198
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University of Malaya
• Contact: Haw Shyan Ng
• Phone: +6 016 483 7722
• Email: plue_chris[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

Drug:
• Aminophylline
aminophylline 150mg
• Frusemide
frusemide 120mg

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients requiring Renal Replacement Therapy (RRT)	Percentage of patients undergoing RRT during ICU stay	throughout ICU stay, an average of 1 month