Individualized Goal-directed Hemodynamic Therapy Targeting Preoperatively Assessed Personal Cardiac Output Values in Patients Undergoing High-risk Surgical Procedures: a Prospective and Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Number of study participants with at least one complication of a composite of 30-day postinterventional complications
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.
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
- Single (Participant)
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
- •Patients ≥ 18 years undergoing a major abdominal procedure (including general, urological, gynaecological, and vascular) with an expected duration of surgery ≥ 90 min or presumed blood loss exceeding 1,000 mL (e.g., intrabdominal vascular surgery) and ≥ 1 of the following high-risk criteria:
- •acute or chronic renal impairment (serum creatinine ≥ 1.3 mg/dL)
- •predefined risk factors for cardiac or respiratory complications
- •Immunodeficiency due to a therapy (e.g., immunosuppressants, chemotherapy, radiation, long-term or high-dose steroids)
- •Immunodeficiency due to specific diseases (e.g., leukaemia, lymphoma, AIDS)
- •severe liver impairment (biopsy proven liver cirrhosis plus 1 of the following: portal hypertension or history of upper gastrointestinal bleeding due to portal hypertension or previous episodes of hepatic insufficiency/hepatic encephalopathy/hepatic coma
- •Age ≥ 80 years
排除标准
- •Age <18 years
- •Pregnancy
- •surgery for palliative treatment
- •emergency procedure
- •refusal of consent
- •participation in another randomized controlled trial
- •failure to meet inclusion criteria
研究组 & 干预措施
Treatment algorithm
Patients allocated to the study group will be connected to a cardiac output monitor. An initial haemodynamic assessment will be performed at the beginning of surgery and at regular time intervals (every 15 minutes) during surgery. The personal cardiac output value is targeted.
干预措施: Treatment algorithm targeting individual cardiac output (Other)
Standard of Care
Patients allocated to the control group will receive the standard care of the hospital.
结局指标
主要结局
Number of study participants with at least one complication of a composite of 30-day postinterventional complications
时间窗: up tp 90 days after study enrollment
composite of 30-day postinterventional complications defined according to the ESA-ESICM guidelines for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine (acute kidney injury stage 1 or higher \[KIDGO\]; ARDS; anastomotic breakdown \[moderate and severe\]; arrhythmia \[severe\]; cardiac arrest; cardiogenic pulmonary oedema \[severe\]; deep vein thrombosis \[moderate and severe\]; delirium; GI bleeding \[severe\]; Infection, source uncertain \[severe\]; bloodstream infection \[severe\]; myocardial infarction \[severe\]; pneumonia \[severe\]; paralytic ileus \[severe\]; postoperative haemorrhage \[severe\]; pulmonary embolism \[severe\]; stroke \[severe\]; superficial, deep, organ/space surgical site infection \[severe\]; urinary tract infection \[severe\]; death)
次要结局
- 7-day-mortality(up to 7 days after study enrollment)
- 30-day-mortality(up to 30 days after study enrollment)
- 90-day-mortality(up to 90 days after study enrollment)
- ICU length of stay(up to 90 days after study enrollment)
- postoperative morbidity survey on days 3, 7, 14, 30(up to 90 days after study enrollment)
- postoperative cognitive dysfunction(up to 90 days after study enrollment)
- Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine(up to 90 days after study enrollment)
- hospital length of stay(up to 90 days after study enrollment)
- perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators(up to 90 days after study enrollment)