跳至主要内容
临床试验/CTRI/2025/03/082235
CTRI/2025/03/082235招募中不适用

Evaluating prognosis in septic shock patient using various perfusion markers during resuscitation

Dr Ekta Tiwari1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
To determine the correlation between the three perfusion markers (lactate level, capillary refill time & P(c-va) co2 gradient) in hospital

研究概览

简要总结

This prospective, observational study will be conducted in the critical care department at Holy Family Hospital, New Delhi, focusing on patients over 18 years of age with septic shock admitted to the ICU. The study will follow the Surviving Sepsis Campaign (SSC) 2021 guidelines for managing septic shock, including optimizing preload with fluid resuscitation and vasopressor infusion to maintain a MAP greater than or equal to 65 mmHg. Various dynamic resuscitation measures, such as pulse pressure variation, inferior Vena cava assessment, and mini fluid challenge, will guide fluid therapy. Safety indicators, such as clinical judgement and lung ultrasound findings, will be used to adjust fluid and vasopressor therapy. A multimodal perfusion assessment will be performed at baseline and at multiple time points (3,6,12 and 24 hours) after resuscitation, including macro-hemodynamic variables, lactate clearance, and peripheral perfusion assessment via capillary refill time. All patients will be followed up until discharge or for 30 days, collecting data on demographics, sepsis sources, management, and clinical parameters for analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients more than 18 years of age admitted in ICU with sepsis shock.
  • 2.Patient presenting with septic shock.
  • (According to sepsis-3 definition, Septic shock is defined as persistent hypotension despite adequate fluid resuscitation and need for vasopressor requirement to target mean arterial pressure (MAP) more than or equal to 65mmhg more than 2 mmol per L blood lactate levels and as per dynamic fluid resuscitation.
  • 3.Patients in those central line can be inserted.

排除标准

  • 1.Age less than 18 years 2.Pregnancy & lactating women 3.Patient with congestive heart failure 4.Patient with active bleed 5.Patient refusing for consent for enrolment in the study 6.Inability to insert central insertion.

结局指标

主要结局

To determine the correlation between the three perfusion markers (lactate level, capillary refill time & P(c-va) co2 gradient) in hospital

时间窗: 0, 3, 6, 12, 24 hours.

次要结局

  • In hospital mortality(30 days)
  • Organ Failure(1st, 3rd day)
  • Vasopressor dose & duration(At discharge)
  • Fluid requirements(12hr, 24 hrs)
  • Need of Invasive mechanical ventilation & duration of mechanical ventilation in days.(At discharge)
  • Need for RRT & number of days on RRT (Renal Replacement Therapy)(At discharge)
  • Cumulative fluid balance(Day1, Day3)
  • ICU & Hospital Length of Stay(At discharge)

研究者

发起方
Dr Ekta Tiwari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ekta Tiwari

Holy Family Hospital

研究点 (1)

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