Acute Kidney Injury
Conditions
Keywords
Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)
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.
Interventions
DRUGAminophylline
aminophylline 150mg
DRUGFrusemide
frusemide 120mg
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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
Intervention model description
double blind, randomised, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Malaysia
Contacts
Primary ContactHaw Shyan Ng
Outcome results
None listed