An observational study to correlate peripheral perfusion index as a predictor of hypotension and mortality in sepsis patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- • To investigate the application of peripheral perfusion index (PPI) in early diagnosis and goal-directed therapy of septic shock, and to provide reference for the early clinical diagnosis and treatment of septic shock.
研究概览
简要总结
OBJECTIVES
• To investigate the application of peripheral perfusion index (PPI) in early diagnosis and goal-directed therapy of septic shock, and to provide reference for the early clinical diagnosis and treatment of septic shock.
MATERIAL AND METHODS
• Type of Study : Prospective Observational Study
• Place of study : Department of Trauma and Emergency
Indira Gandhi Institute Of Medical Sciences,Sheikhpura Patna
• Period of Study: 2 month
• Approval from the ethical committee was obtained .
• Adult patients with sepsis admitted to Trauma & Emergency department’s intensive care unit (ICU).
• Group 1– The PPI group will be defined using PPI < 1.4 as diagnosis of septic shock standard, and PPI > 2 as treatment guide target.
• Group 2 – Control group. Control group will be defined according to the traditional diagnostic criteria of shock which systolic blood pressure will be less than 90 mmHg (1 mmHg = 0.133 kPa) or systolic blood pressure value decrease > 40 mmHg baseline and bundle treatment will be performed.
The volume of fluid resuscitation, organ dysfunction, the sequential organ failure score (SOFA), acute physiology and chronic health evaluation II (APACHE II) score, continuous renal replacement therapy (CRRT) time, mechanical ventilation (MV) time, the length of ICU stay and 28-day mortality will be observed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The study selected consecutive adult patients admitted with the diagnosis of septic shock or within 24 h after septic shock onset in patients previously admitted for other causes.
- •According to internationally accepted consensus definitions at the time of beginning of study , sepsis will be defined based on clinical evidence of infection and two or more of the following: fever axial temperature greater than 38°C or hypothermia axial temperature LESS THAN 36°C, tachycardia heart rate more than 90 beats per min, tachypnea more than 20 breaths per minute or need for mechanical ventilation, leukocytosis m ore than 12 000 cells/mm3 or leukopenia less than 4,000 cells/mm3, or a ratio of greater than 10% band cells to polymorphonuclear cells.
- •Septic shock will be defined as sepsis with hypotension (mean arterial pressure less than 65 mm Hg and/or hypoperfusion represented by hyperlactatemia more than 2.0 mmol/L, irrespective of blood pressure, even after initial volume expansion and requiring vasopressors..
排除标准
- •Other causes of shock,severe hepatopathy or coagulopathy platelets less than or equal to 20,000/mm3,international normalizated ratio more than 2.0, or activated partial thromboplastin time- aPTT more than 70 s, infective endocarditis, systemic sclerosis, and severe obstructive arterial disease.
- •These criteria will be chosen to reduce the risks of possible hemorrhagic and ischemic complications of procedures.
- •Patients with cardiac arrhythmias or active or severe bleeding will be also excluded from the protocol for assessing adrenergic stimulus that is increase of vasopressors doses.
结局指标
主要结局
• To investigate the application of peripheral perfusion index (PPI) in early diagnosis and goal-directed therapy of septic shock, and to provide reference for the early clinical diagnosis and treatment of septic shock.
时间窗: • At the time of admission | then every 6 hourly for first 24 hour then weekly and at last 28 days mortality benifit
次要结局
- early treatment for sepsis and mortality benefit(patients admitted with the diagnosis of septic shock or within 24 h after septic shock onset in patients previously admitted for other causes.)
研究者
DR RAJ BAHADUR SINGH
IGIMS,Patna