Impact of Continuous Renal Replacement Therapy on Systemic Hemodynamics and Lactate Clearance in Critically Ill Cirrhotics With Septic Shock.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement of SVR from baseline by 20% or above 600 and decrease in vasopressors at 24 hours after CRRT initiation.
研究概览
简要总结
Consecutive critically ill cirrhotics with septic shock and AKI who give written informed consent will be included in this prospective study. A blood and urine sample (~10 ml) would be stored for assessing the serum cytokine profile, endotoxin levels, NT-Pro BNP, Troponin I levels, urine N-GAL before, 6 hours and at 24 hours after initiation of CRRT. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of SVR, SVRI, global ejection fraction, extravascular lung water index and pulmonary vascular permeability index, CVP, IVC diameter and B-lines on ultrasound lung would be recorded. A record of the clearance of lactate at 6, 12 , 24 and daily till recovery or death would be performed. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
详细描述
AIM: Assessment of the impact of CRRT on systemic hemodynamics and microcirculation in critically ill cirrhotics with septic shock and AKI.
Primary Objective To study the impact of continuous renal replacement therapy on systemic hemodynamics (improvement in systemic vascular resistive index, cardiac index) and lactate clearance in critically ill cirrhotics with septic shock.
Secondary Objectives Impact on endothelial function and inflammatory cytokines Impact on renal functions and ammonia Incidence of hemodynamic instability and/or intradialytic hypotension Impact on lung injury scores (as determined by EVLW and PVPI) To study the duration of mechanical ventilation and ICU stay Impact on transplant-free survival To evaluate the improvement in SOFA, MELD and APACHE scores.
Methodology: Consecutive critically ill cirrhotics with septic shock and AKI who give written informed consent will be included in this prospective study. A blood and urine sample (~10 ml) would be stored for assessing the serum cytokine profile, endotoxin levels, NT-Pro BNP, Troponin I levels, urine N-GAL before, 6 hours and at 24 hours after initiation of CRRT. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of SVR, SVRI, global ejection fraction, extravascular lung water index and pulmonary vascular permeability index, CVP, IVC diameter and B-lines on ultrasound lung would be recorded. A record of the clearance of lactate at 6, 12 , 24 and daily till recovery or death would be performed. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill cirrhotics undergoing continuous renal replacement therapy.
排除标准
- •Patients with age less than 18 years
- •Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
- •Chronic kidney disease on hemodialysis
- •Extremely moribund patients with an expected life expectancy of less than 24 hours
- •Failure to give informed consent from family members.
- •Hemodynamic instability requiring very high dose of vasopressors.
- •Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation.
结局指标
主要结局
Improvement of SVR from baseline by 20% or above 600 and decrease in vasopressors at 24 hours after CRRT initiation.
时间窗: 24 hours
次要结局
- Lactate clearance after CRRT initiation(24 hours)
- Incidence of renal recovery(24 hours)
- Incidence of dialysis associated complications (hypotension, bleeding, hypothermia, catheter-related blood stream infections would be recorded).(24 hours)