Clinical trial

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

Name
202334-12198
Description
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.
Trial arms
Trial start
2023-07-02
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Aminophylline
aminophylline 150mg
Arms:
Treatment group
Frusemide
frusemide 120mg
Arms:
Control group, Treatment group
Other names:
Lasix
Size
132
Primary endpoint
Percentage of patients with effective diuresis at 6 hours post intervention
6 hours post intervention
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind, randomised, controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}
Updated at
2023-07-11

1 organization

2 products

1 indication

Product
Frusemide