The Role of Granulocyte-Colony Stimulating Factor (G-CSF) for Improving PELD Score and Nutritional Status in Pediatric Liver Cirrhosis Prior to Liver Transplantation Through Immunomodulation of Neutrophil, CD34+ Cell, TNF-α and IL-10
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PELD Score
研究概览
简要总结
This study compares the effect of human recombinant Granulocyte-Colony Stimulating Factor (G-CSF) in pediatric patients with liver cirrhosis with a control group. The study aims to observe improvement of (Pediatric End-stage Liver Disease) PELD score and nutritional status prior to liver transplantation procedure. In addition to the intervention, standard treatments for liver cirrhosis are also given for both groups. G-CSF is administered for 12 times.
Condition of disease:
Pediatric patient aged 3 months to 12 years old Liver cirrhosis Undernourished / Severe malnutrition PELD score 10-25
Intervention:
Drug: Recombinant Human G-CSF
Phase:
Phase 3
详细描述
This open-label randomized control trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, aimed to determine the effect of G-CSF to improve PELD score and nutritional status of pediatric patients with liver cirrhosis prior to liver transplantation. A total of 52 pediatric patients with liver cirrhosis, malnutrition and PELD score between 10-25 will be collected and divided into intervention group and control group. The intervention group will be given a subcutaneous injection of G-CSF 5μg/kg/day for 5 days consecutively, followed by a single dose every 3 days up to 12 times throughout the trial. Additionally, both the intervention and control group receive standard liver cirrhosis treatment. Randomization is done using block randomization.
The patients will be clinically monitored and evaluated for anthropometric changes (body weight, mid-arm circumference, mid-arm muscle circumference, and triceps skinfold thickness), complete blood count, absolute neutrophil count, liver function tests, cytokines (IL-10, TNF-α), Procalcitonin, hepatocyte growth factor (HGF), CD34+ cell count and PELD score (albumin, bilirubin, prothrombin and international normalized ratio values).
Data analysis will be performed using IBM SPSS Statistics version 20.0.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 3 months to 12 years old
- •Conscious state
- •Without the presence of fever (temperature: <37,5°C)
- •Decompensated liver cirrhosis
- •Liver cirrhosis due to various etiology
- •Undernourished or severe malnutrition
- •PELD score between 10-25
排除标准
- •Malignancy (liver origin or other types)
- •History of undergoing any organ transplantation procedure
- •Acute liver failure
- •Failure of any organ other than the liver
- •Encephalopathy
- •Severe infection such as bacterial peritonitis and pneumonia
研究组 & 干预措施
Treatment Group
Subcutaneous injection of G-CSF with dose of 5μg/kg/day for 5 days consecutively, in addition to a single dose every 3 days up to 12 times, as well as liver cirrhosis standard regimen
干预措施: G-CSF (Filgrastim) (Drug)
结局指标
主要结局
PELD Score
时间窗: 90 days
The scoring determines the individual's need for liver transplant. Calculation is based on an equation that incorporates the values of bilirubin serum, international normalized ratio, albumin and body growth measurement. Score ranges between 6 (low illness level) to 40 (severely ill).
Anthropometric Changes
时间窗: 90 days
Measurement of mid-arm circumference (MAC) will be obtained in centimeters and be plotted on the curve to observe changes in nutritional status
次要结局
- Pro-inflammatory Marker(30 days)
- Liver Regeneration Marker(30 days)
- Anti-inflammatory Marker(30 days)
研究者
Tri Hening Rahayatri
Principal Investigator
Fakultas Kedokteran Universitas Indonesia