Effect of High Volume Hemodiafiltration on Lung Oxygenation, Lung Mechanics and Biomarkers in Mechanically Ventilated Patients With Severe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arterial oxygen pressure (PaO2)
研究概览
简要总结
High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit.
详细描述
Sepsis, defined as life-threatening organ dysfunction caused by dysregulated immune response to infection. Hemofiltration has been suggested as beneficial in restoring immune homeostasis. High volume hemodiafiltration (HVHDF) is a hybrid method of intermittent renal replacement therapy (RRT), where high filtration volumes are applied. In several studies; higher filtration volumes have been shown to achieve hemodynamic improvement and possibly survival benefit in patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:
- •Mental clouding: decreased glasco coma scale GCS < 15
- •Hypotension: Systolic blood pressure < 100 mmgH
- •Tachypnea: respiratory rate > 22 breath/ minute Then serum lactate is analysed to confirm sepsis hypoperfusion if ≥ 2mmol/L
- •Organs dysfunction (including one of them respiratory failure).
- •Organ dysfunctions are defined as following:
- •Respiratory dysfunction (criteria for ARDS):
- •PaO2/FiO2 <200
- •Bilateral infiltrates in chest X-ray
- •Resistant hypoxemia
- •Tachypnoea (RR > 40 breath/minute)
- •The need for invasive mechanical ventilation
- •Excluded cardiac causes of pulmonary edema
- •CNS failure:
- •Decreased GCS ≥ 4 decreased points
- •CVS dysfunction:
- •Sustained hypotension even on very high inotropes doses (Noradrenaline >1µm/min)+ adrenaline>1.5µm/min associated
- •with high CVP pressure > 12 mmHg and not responding to fluid challenge test to exclude hypovolemia.
- •Cardiomegaly detected by either echocardiography assessment, or chest X-ray
- •Resistant frequent ventricular ectopics not explained by organic causes.
- •Liver dysfunction:
- •Elevated total and direct bilirubin than double normal or basal levels
- •Elevated prothrombin time > 17 seconds or INR > 1.5
- •Elevated liver enzymes > triple normal level
- •Renal dysfunction:
- •Decreased urine output < 0.5 ml/kg.
- •Elevated creatinine level > 164 µmol/L (1.5mg/dL).
- •Decreased creatinine clearance <50ml/minute if available.
- •Bone marrow depression:
- •Decreased platelets < 90 X 103/µL
- •Decreased leukocytes <4 X 103/µL
- •Decreased RBCs count < 4 X 106/µL
排除标准
- •Patient relatives' refusal
- •Recent active internal hemorrhage
- •Not mechanically ventilated.
- •Hypersensitivity to the dialyser fluid
研究组 & 干预措施
Group A (controlled group)
They will not receive HVHDF treatment
干预措施: controlled (Other)
Group B (HVHDF group)
They will receive HVHDF treatment for 48 hours. HVHDF will be performed via indwelling central venous catheter. The blood flow will be 180-240 ml/min, and ultrafiltration rate will be 70 ml/kg/h during HVHF. The substitute fluid will be infused with pre-dilution. Heparin will be used for anti-coagulation, whose initial dose will be 15-25 U/kg, and maintenance dose is 5-15 U/kg/h. aPTT time maintained between 60-80 second and will be checked every 12 hours. The survival status of all of the subjects were followed up at 28 days after being diagnosed as severe sepsis.
干预措施: HVHDF (Other)
结局指标
主要结局
Arterial oxygen pressure (PaO2)
时间窗: 24 hours after start of HVHDF
Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)
次要结局
- Ventilatory function(0 hour, 24 hours, and 48 hours after start of HVHDF)
- The ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)(0 hour, 24 hours, and 48 hours after start of HVHDF)
- The duration for weaning from mechanical ventilation (MV)(28 days)
研究者
Ayman Abd El-Khalek Mohammed Glala
Ayman Abd ELkhalek Mohammed, lecturer, clinical anesthesiologist and principal investigator
Assiut University