Multi-center Clinical Trial of Lactate Clearance Goal-directed Fluid Resuscitation in Patients With Sepsis
试验速览
- 阶段
- 不适用
- 入组人数
- 1,128
- 试验地点
- 1
- 主要终点
- 28-d mortality
研究概览
简要总结
Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated "We suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion", with weak recommendation and low quality of evidence. Several trials which evaluated the resuscitation strategy included lactate clearance as a target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results. The aim of this study is to explore the feasibility of lactate clearance guide resuscitation in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic shock through multi-center, central-randomization clinical trial.
详细描述
Sepsis remains a great challenge for clinicians, early goal-directed therapy(EGDT), referring to a number of target-achieving indicators including systemic central venous oxygen saturation(ScvO2) after initial fluid resuscitation within 6 hours, has been one of the main treatment for sepsis. ScvO2 is the only indicator that reflects tissue oxygen metabolism. However, there're studies confirmed that ScvO2 oriented EGDT cannot reduce the mortality of sepsis. So it is important to find out a more effective indicator. Lactic acid is a product of anaerobic metabolism of the body, lactate clearance has been found to effectively predict the prognosis of sepsis. Few studies have shown that lactate clearance oriented fluid resuscitation can be of benefit in patients with sepsis. Nevertheless, whether lactate clearance could be combined with sepsis Bundle as a new marker to improve the prognosis remains a problem. The objective of this study is to discuss the feasibility of lactate clearance oriented sepsis treatment through multi-center clinical trial.
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, Outcomes Assessor)
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
- •Older than 17 years old.
- •Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).
- •Be transferred to intensive care unit (ICU) for the first time during this hospitalization.
- •Elevated lactate ≥3.0mmol/L.
排除标准
- •Acute hemorrhage uncontrolled.
- •Pregnancy.
- •Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.
- •Known being in an immunosuppressive state:
- •Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy.
- •Known human immunodeficiency virus (HIV) serology positive.
- •Known chronic kidney disease.
- •Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia.
- •Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week.
- •Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.
研究组 & 干预措施
Lactate clearance 10% target group
Lactate clearance falls by 10-percent every two hours.
干预措施: Lactate clearance 10% target group (Behavioral)
Lactate clearance 20% target group
Lactate clearance falls by 20-percent every two hours.
干预措施: Lactate clearance 20% target group (Behavioral)
Standard EGDT group
Refer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation.
干预措施: Standard EGDT group (Behavioral)
结局指标
主要结局
28-d mortality
时间窗: Four years
All-cause mortality at 28 days
次要结局
- ICU Length of stay(Four years)
- Hospital Length of stay(Four years)
- 90-d mortality(Four years)
- Adverse events(Four years)
- In-ICU mortality(Four years)
- Administered treatments(Four years)
- SOFA at 24h(Four years)
- In-hospital mortality(Four years)