Acute Kidney InjuryPhase 2/3NCT05933642
Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
A Phase 2/3 study testing Aminophylline and Frusemide in people with Acute Kidney Injury, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Aminophylline and Frusemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Jul 2023to 31 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya
Kuala Lumpur, 50603
Haw Shyan Ng, MBBS, 0164837722, plue_chris@yahoo.co.uk
About this study
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Aminophylline, Frusemide
- Keywords
- Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllineDrug
aminophylline 150mg
FrusemideDrug
Also called Lasix
frusemide 120mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | 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 Receives: Drug: Aminophylline; Drug: Frusemide |
| Control group | Active comparator | IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour Receives: Drug: Frusemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours post intervention
Secondary outcomes (6)
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
Measured: 2 hours post intervention
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
Measured: Up to 6 hours post interventions
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
Measured: 6 hours post interventions
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
Measured: 1 day post 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
Measured: 1 day post intervention
Percentage of patients requiring Renal Replacement Therapy (RRT)
Percentage of patients undergoing RRT during ICU stay
Measured: throughout ICU stay, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start2 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind, randomised, controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ng Haw Shyan, University of Malaya
- Investigators
- Haw Shyan Ng, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933642
- Sponsor's protocol ID
- 202334-12198
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT05933642
- Acronym / sponsor ID
- 202334-12198
- Conditions
- Acute Kidney Injury
- Keywords
- Aminophylline, Furosemide, Critically ill, Adults, Intensive Care Unit (ICU)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind, randomised, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Aminophylline, Drug: FrusemideIntravenous (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 |
| Control group | Active comparator | Drug: FrusemideIV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophyllineaminophylline 150mg | Drug | Treatment group |
| FrusemideAlso: Lasixfrusemide 120mg | Drug | Control group, Treatment group |
Primary outcome
Percentage of patients with effective diuresis at 6 hours post intervention
Time frame: 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 secondary outcomes
Percentage of patients with effective diuresis at 2 hours post intervention
Time frame: 2 hours post intervention
Mean duration of infusion to achieve effective diuresis post intervention
Time frame: Up to 6 hours post interventions
Changes in urine output at 6 hours post intervention
Time frame: 6 hours post interventions
Changes in serum creatinine at 1 day post intervention
Time frame: 1 day post intervention
Changes in serum eGFR at 1 day post intervention
Time frame: 1 day post intervention
Percentage of patients requiring Renal Replacement Therapy (RRT)
Time frame: throughout ICU stay, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haw Shyan Ng principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aminophylline and Frusemide in people with Acute Kidney Injury, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haw Shyan Ng (+6 016 483 7722, plue_chris@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with effective diuresis at 6 hours post intervention (time frame: 6 hours post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.