Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization - Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prevention of post-embolization syndrome
研究概览
简要总结
N-acetylcysteine (NAC), a glutathione precursor and potent antioxidant, is known as a liver protector. As a steroid preparation, dexamethasone is known to have efficient anti-inflammation and immunosuppression effects. N-acetyl cysteine and Dexamethasone's roles in preventing post-embolization syndrome following TACE have each been researched individually in the past. Up until now, no study has been done that has compared dexamethasone and NAC in post-embolization syndrome. With this study, we aim to study the efficacy of combining dexamethasone with N-acetyl cysteine in the prevention of post-embolization syndrome within 72 hours among patients who undergo transarterial chemoembolization for HCC.
详细描述
Aim & Objectives Hypothesis: The combination of dexamethasone with NAC is superior to NAC alone in prevention of PES among patients who undergo TACE in HCC as both medications work differently to prevent PES.
AIM:- To study the efficacy of combining Dexamethasone to N acetyl cysteine in prevention of post embolization syndrome within 72 hours among patients who undergo transarterial chemoembolization for HCC.
Objective - PRIMARY Prevention of post embolisation syndrome within 72 hours.
SECONDARY
- Prevention of post embolisation decompensation at 2 weeks.
- Decrease in the duration of hospitalization.
- To study the adverse effects of NAC and steroids in patients who undergo transarterial chemoembolisation for HCC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing TACE procedure
- •Valid Consent
- •Age 18-65 years
排除标准
- •Child Pugh C, Child Pugh B > 8
- •HCC patients with a curative therapy (Ablation, Resection or LT)
- •ECOG Performance Status 3-4
- •Pregnancy
- •History of allergic reaction from NAC
- •significant cardiopulmonary disease
- •UGI bleed within last 28 days
- •Recent surgery within last 28 days
- •Documented febrile illness in last 1 weeks
- •Uncontrolled Diabetes (FBS > 200, HBA1C > 8)
- •Uncontrolled Hypertension (BP > 160/100)
- •Structural kidney disease with eGFR < 60 ml/min
研究组 & 干预措施
NAC+Dexamethasone
NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.
干预措施: N Acetylcysteine (Drug)
NAC+Dexamethasone
NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
Dexamethasone 20 mg in 5 ml NS 1 hour prior to procedure and 8 mg in 5 ml NS at day 2, day 3. Placebo 5 ml NS 1 hr prior to procedure.
干预措施: Dexamethasone (Drug)
NAC+Placebo
NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
干预措施: N Acetylcysteine (Drug)
NAC+Placebo
NAC started at 12 hr prior to procedure - (150 mg/kg/hr for 1 hr followed by 12.5 mg/Kg/hr for 4 hr, then continuous infusion of 6.25 mg/h for 48 after the procedure.
干预措施: Placebo (Other)
结局指标
主要结局
Prevention of post-embolization syndrome
时间窗: 72 hours
Prevention of Post-embolization syndrome , Defined base on South west oncology group (SWOG) toxic coding less than 2 score
次要结局
- Decrease in the duration of hospitalisation(4 weeks)
- Prevention of post TACE decompensation at 4 weeks(4 weeks)
- Adverse events of Dexamethasone and NAC in patients undergoing transarterial chemoembolisation for HCC(2 weeks)