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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminophylline | Drug | aminophylline 150mg |
| |
| Frusemide |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean duration of infusion to achieve effective diuresis post intervention |
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Inclusion Criteria:
Exclusion Criteria:
Patient with existing peptic ulcer disease or coagulopathy with INR > 1.5
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haw Shyan Ng | Contact | +6 016 483 7722 | plue_chris@yahoo.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Haw Shyan Ng | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya | Recruiting | Kuala Lumpur | 50603 | Malaysia |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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double blind, randomised, controlled trial
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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
| Drug |
frusemide 120mg |
|
|
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 |
| 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 |
| 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 |
| 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 |
| Percentage of patients requiring Renal Replacement Therapy (RRT) | Percentage of patients undergoing RRT during ICU stay | throughout ICU stay, an average of 1 month |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |