A randomized controlled trial to compare the efficacy of Corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare mortality risk in steroid group and steroid plus granulocyte stimulating factor group
研究概览
简要总结
To compare the efficacy of corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients.
AIMS AND OBJECTIVES
AIM:
A randomised controlled trial to compare the efficacy of corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients.
OBJECTIVE:
Primary outcome:
To compare 30 days and 90-days mortality risk between the groups.
Secondary outcome:
To study improvement in MELD scores in the two groups at 30 and 90-days.
-
Patients who qualifies the criteria for severe alcoholic hepatitis, Inclusion and Exclusion criteria, valid consent will be taken from the study population,in the language best understood by them and after explaining them the study in detail.
-
Patients will be randomly allocated to one of the two groups on a 1:1 randomization ratio(Group A and Group B)
Randomization will be performed using computer generated random number list
Group A: participants who were started on steroids with standard medical therapy. Response to steroids was assessed by Lille Model score with<0.45 on day 7 and those responding to steroids were continued in group A and those not responding were excluded from the study.
Group B: participants in this group were started on GCSF and Steroids and were assessed by Lille Model score with<0.45 on day 7 responders were continued on combination therapy while non responders were continued with GCSF alone.
Group A with Group B outcomes were compared and also Group A with non-responders of subgroup of B in which GCSF alone was continued, were also compared. At the end of study, we analyzed and compared 30- and 90-days mortality risk and adverse events in both the study groups.
Intervention/Treatment:
Arm 1: Drug Prednisolone 40 mg for initial 7 days. Responders as per Lille model score of <0.45 on day 7 were continued Prednisolone 40 mg daily for a total of 28 days and were taper steroids accordingly.
Arm 2: Drug Granulocyte colony stimulating factor (GCSF) 300 mcg daily and Prednisolone 40 mg for 7 days and who were favorable to Lille model score were continued both Granulocyte colony stimulating factor (GCSF) 300 mcg every three days and Prednisolone 40 mg daily for total 28 days and were tapered the steroids accordingly. Patients who were non-responders as per Lille model score were given only Granulocyte colony stimulating factor (GCSF) 300 mcg once in every 3 days for 28 days.
The enrolled subjects were asked to follow- up weekly for improvement in symptoms and various predefined parameters , primary and secondary outcomes were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Severe alcoholic hepatitis patients with Maddreys Score more than 32 Age between 18 to 65 yrs.
排除标准
- •Patients with ongoing infections Patients with pregnancy Patients with severe renal derangement of serum creatinine more than 2.5 Patients with active gastrointestinal bleed Patients with viral hepatitis.
结局指标
主要结局
To compare mortality risk in steroid group and steroid plus granulocyte stimulating factor group
时间窗: Mortality risk will be assessed at 30 days and 90 days
次要结局
- To compare the values of MELD scores in steroid group & steroid plus granulocyte stimulating factor group(To compare MELD score at 30 days & 90 days)
研究者
Dr Koushik Chavalla
Bharati Vidyapeeth (Deemed to be) University Medical College