Back to resultsDiuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
Primary Purpose
Acute Kidney Injury
Status
Recruiting
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Aminophylline
Frusemide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)
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
Sites / Locations
- University of MalayaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
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
IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
Percentage of patients requiring Renal Replacement Therapy (RRT)
Percentage of patients undergoing RRT during ICU stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05933642
Brief Title
Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
Official Title
Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
double blind, randomised, controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Intervention Description
aminophylline 150mg
Intervention Type
Drug
Intervention Name(s)
Frusemide
Other Intervention Name(s)
Lasix
Intervention Description
frusemide 120mg
Primary Outcome Measure Information:
Title
Percentage of patients with effective diuresis at 6 hours post intervention
Description
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
Time Frame
6 hours post intervention
Secondary Outcome Measure Information:
Title
Percentage of patients with effective diuresis at 2 hours post intervention
Description
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
Time Frame
2 hours post intervention
Title
Mean duration of infusion to achieve effective diuresis post intervention
Description
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
Time Frame
Up to 6 hours post interventions
Title
Changes in urine output at 6 hours post intervention
Description
Difference of hourly urine output (ml/hour) measured immediately before starting intervention and 6 hours post intervention
Time Frame
6 hours post interventions
Title
Changes in serum creatinine at 1 day post intervention
Description
Difference of serum creatinine in mmol/l on the day of intervention and one day after intervention
Time Frame
1 day post intervention
Title
Changes in serum eGFR at 1 day post intervention
Description
Difference of serum eGFR in mL/min/1.73m2 on the day of intervention and one day after intervention
Time Frame
1 day post intervention
Title
Percentage of patients requiring Renal Replacement Therapy (RRT)
Description
Percentage of patients undergoing RRT during ICU stay
Time Frame
throughout ICU stay, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haw Shyan Ng
Phone
+6 016 483 7722
Email
plue_chris@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haw Shyan Ng
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haw Shyan Ng, MBBS
Phone
0164837722
Email
plue_chris@yahoo.co.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
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