Comparison Of Lactulose versus Polyethylene Glycol In Management Of Hepatic Encephalopathy In Pediatric Acute Liver Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- o Measured from first dose administration
研究概览
简要总结
This study will systematically assess the comparative efficacy of PEG and lactulose in PALF-associated HE, addressing a critical gap in pediatric hepatology and aiming to provide evidence-based guidance for management in PALF.
In this study, children with PALF will be randomised to receive either laxative Lactulose or Polyethylene glycol and time to improvement in HE will be assessed and compared, with the hypothesis being that Polyethylene glycol is superior to lactulose in earlier resolution of hepatic encephalopathy in PALF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with signs and symptoms of liver dysfunction fulfilling all the following criteria will be included:
- •Age: 1 month.
- •INR more than or equal to 1.5 (without vitamin K deficiency)
- •Evidence of hepatic encephalopathy (any grade)
- •Acute onset liver dysfunction (<8 weeks)
- •Written informed consent from parent/guardian
- •Assent when age-appropriate.
排除标准
- •Children fulfilling the inclusion criteria but having any of the following will be excluded: o Known chronic liver disease o Prior neurological disorders affecting HE assessment.
结局指标
主要结局
o Measured from first dose administration
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
o Improvement must be sustained for AT LEAST 12 hours
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
o Assessment by blinded evaluator (DM Pediatric Gastroenterology
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
trainee in the study department, not directly involved in the trial)
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
Time to improvement defined as:
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
Decrease by at least one grade on West Haven Criteria OR PALFSG Criteria
时间窗: at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted.
次要结局
- TIME TO COMPLETE RESOLUTION OF HEPATIC ENCEPHALOPATHY(24 HOURS, 48 HOURS AND 72 HOURS SINCE ADMISSION)
- NEED FOR MECHANICAL VENTILATION(DISCHARGE OR DEATH)
- NEED AND LENGTH OF PICU STAY(DISCHARGE OR DEATH)
- DURATION OF HOSPITAL STAY(DISCHARGE OR DEATH)
- 28 DAY SURVIVAL STATUS AND LIVER FUNCTION(28 DAYS POST DISCHARGE)
研究者
Dibyendu Sekhar Das
AIIMS Rishikesh