Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Percentage of patients with effective diuresis at 6 hours post intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment group
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
干预措施: Aminophylline (Drug)
Treatment group
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
干预措施: Frusemide (Drug)
Control group
IV infusions of furosemide (120mg diluted to 50ml NS), IV load 10ml over 60 minutes, followed by IV infusion of 4 ml/hour
干预措施: Frusemide (Drug)
结局指标
主要结局
Percentage of patients with effective diuresis at 6 hours post intervention
时间窗: 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
次要结局
- Mean duration of infusion to achieve effective diuresis post intervention(Up to 6 hours post interventions)
- Percentage of patients with effective diuresis at 2 hours post intervention(2 hours post intervention)
- Changes in urine output at 6 hours post intervention(6 hours post interventions)
- Changes in serum creatinine at 1 day post intervention(1 day post intervention)
- Changes in serum eGFR at 1 day post intervention(1 day post intervention)
- Percentage of patients requiring Renal Replacement Therapy (RRT)(throughout ICU stay, an average of 1 month)
研究者
Dr Ng Haw Shyan
Principal Investigator
University of Malaya