The Effect of Steroids in Paediatric Septic Shock in Addition to Standard Care on Length of Hospital Stay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect of steroids in paediatric septic shock in addition to standard care on length of hospital stay
研究概览
简要总结
After obtaining Institutional Ethics Committee approval and written informed consent from the patients, 25 patients per group will be enrolled for the study. Screening will be done using a predesigned performa for eligibility of the child for inclusion in the study.
If the child is eligible for study, consent will be obtained and the child will be randomly assigned to one of the study intervention, study intervention will be started and data will be collected.
Study group will recieve one of the two intervention either Hydrocortisone as interventional steroid alongwith standard care and other group will receive standard care alone. Reconstituted hydrocortisone or placebo will be supplied to the treating nursing officer by central pharmacy with a label of alpha numeral code, which will be available with central pharmacy which will not be in contact with investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group- children 1-18 years old With suspected sepsis Phoenix sepsis score more than or equal to 2.
排除标准
- •Immunocompromised patients Patients with adrenal disease Patients with Pituitary diseases Patients with history of long term steroids i.e six months or patients on short term steroids in past 4 weeks.
- •Tuberculosis patients.
结局指标
主要结局
Effect of steroids in paediatric septic shock in addition to standard care on length of hospital stay
时间窗: Calculated in number of days from date of randomization of the patient in the study to the date of discharge/death of the patient.
次要结局
- Time to Shock reversal(Defined as cessation of ionotropes/vasopressors for a minimum duration of 24 hours)
- Length of PICU stay
- To study effect of steroids as compared to placebo on mortality in paediatric septic shock.(Defined from date of randomization to date of death of patient.)
研究者
Dr Sudha Chandelia
ABVIMS and Dr RML Hospital