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临床试验/CTRI/2025/03/083025
CTRI/2025/03/083025尚未招募2 期

Comparison Of Efficacy Of Levosimendan Versus Milrinone In Catecholamine Resistant Septic Shock With Myocardial Dysfunction In Children : A Single-Center, Open-Label Randomized controlled Trial

ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels.

研究概览

简要总结

  1. Patients presenting to Paediatric department of AIIMS Patna (meeting inclusion criteria) will be randomly allocated in 1:1 ratio to two independent treatment groups using opaque sealed envelope method:

Group A: Receives  levosimendan as an  ionodilator drug therapy

Group B: Receives  milrinone  as an ionodilator  drug therapy

After sample selection as per inclusion criteria after randomization children were started on either milrinone or levosimendan. As levosimendan is in powder form, it will be diluted in 5ml normal saline (standard dilution) to make clear fluid. Milrinone is available as clear fluid and both of these drug is stable for more than 24 hours at room temperature when given as an infusion However if shock persists after the study protocol treating team may further decide the use of any inotrope as open label as per type of shock & clinical profile of the patient using their description

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
1.00 Month(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • All the patients admitting in Paediatric emergency and pediatric intensive care unit, AIIMS Patna, with diagnosis of catecholamine resistant septic shock with and cardiac Index less than 3.3L/MIN/M2.

排除标准

  • Patient requiring CPR at presentation Cardiomyopathy, cardiothoracic surgery within the previous 14 days.
  • congenital heart disease.

结局指标

主要结局

improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels.

时间窗: 1 DAY

次要结局

  • Time taken for improvement in cardiac function, survival outcome.

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Pawan Kumar

AIIMS, Patna

研究点 (1)

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