A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- haemodynamic effects
研究概览
简要总结
A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients
详细描述
This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible for the trial if they meet all of the following criteria:
- •Age criteria: 18 - 90 years
- •Septic shock - Sepsis 3 criteria :
- •acute change in total SOFA score ≥ 2 due to infection
- •use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
- •blood lactate level ≥ 2 mmol/L within last 24 hours
- •Likely need for fluid resuscitation
- •poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation < 70% iv. clouded sensorium/poor mentation
- •dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both > 12% iii. distensibility index of inferior vena caval diameter > 12%
- •Signed the relevant informed consent form
排除标准
- •Subjects will not be eligible for the trial if they meet any of the following criteria:
- •Poor transthoracic echo windows
- •Actual body weight > 160 kg
- •Hypernatremia: [Na] > 150 mEq/L
- •Cardiac tamponade
- •Uncorrected severe valvular heart disease or life-threatening arrhythmia
- •Moribund patients likely to die before the study protocol is completed
- •Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L
- •Severe liver dysfunction defined by total serum bilirubin > 120 umol/l
- •Pregnancy and lactation
研究组 & 干预措施
Group 2
Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)
干预措施: 3% NaCl (Drug)
Group 1
Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)
干预措施: Sodium Lactate (Drug)
结局指标
主要结局
haemodynamic effects
时间窗: at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus
SV is the amount of blood that leaves the left ventricle with every beat cycle and is calculated by measuring the Doppler flow in the aortic valve. Unit: ml
次要结局
- acid-base effect(at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus)
- anti-inflammatory effect(parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.)
- Safety - Incidence of adverse events and reactions(30 days after intervention)