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临床试验/CTRI/2024/09/073205
CTRI/2024/09/073205尚未招募Phase 3 4

Active bundle De Resuscitation in Septic shock : A Randomized controlled trial

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Cumulative negative fluid balance at day 3 and VExUS less than 1

研究概览

简要总结

Aims and objectives: This study aims to investigate the fluid de resuscitation have negative cumulative fluid balance on day 3 and patient centered outcomes

Methodology: All patient satisfying the inclusion criteria will be included in the study after obtaining written informed consent from patients’s relatives. Data collection includes demographic details, comorbidities, primary diagnosis, operative status, SOFA score, APACHE 2 score, baseline vitals ( Heart rate, blood pressure, respiratory rate, spo2) , baseline arterial blood gas ( P/F ratio, lactate ). The decision regarding de resuscitation will be taken by the intensive care physician as per study protocol. Before de resuscitation cumulative fluid balance will be measured at the time randomization.  The patient will be randomized in 1;1 ratio in the following 2 groups, Active de resuscitation group ( fluid restriction, limb elevation with compression bandage application, administering furosemide infusion at rate of 10mg/hour , maximum dose upto 240 mg/day) and standard of care group. All patients included in the study will undergo daily measurement of fluid balance and VExUS score for first 3 days ( day 1,2,3). Target of intervention wil be equibalance of fluid on day 1, negative fluid balance on day 3 and VExUS less than 1. Patient will be excluded from studies if any of the following condition after randomization

  1. Hypotension ( Mean arterial pressure less than 65 mmHg)

  2. persistent and increasing vasopressor requirement ( Nor adrenaline more than 0.15 mcg/kg/min)

  3. secondary infection

  4. lactate > 4 mmol/l

  5. Hypernatremia ( serum sodium > 155 meq/l)

  6. Hypokalemia and metabolic alkalosis

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 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with septic shock resolution the lactate level less than 4 mmol/l and nor adrenaline dose less than 0.15microgram/kg/min.
  • Patients with cumulative positive fluid balance more than 2 litre and VExUS more than 1.

排除标准

  • 1.Patients age less than 18 years 2.Pregnancy and lactating women
  • CKD (chronic kidney disease)
  • CLD (chronic liver disease) 5.Solid organ and Hematopoietic stem cell transplant patients
  • Burn injury patients
  • Patient is on chronic dialysis
  • Anuric patient.

结局指标

主要结局

Cumulative negative fluid balance at day 3 and VExUS less than 1

时间窗: 3 days

次要结局

  • Need of Renal Replacement therapy on day 3(day 1 to 3)
  • acute kidney injury on day 3(day 1 to 3)
  • ventilator free days(day 1 to 30)
  • vasopressor free days(day 1 to 30)
  • 30 days mortality(day 30)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Sugumar M

All India Institute of Medical Sciences , New Delhi

研究点 (1)

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