Does Perioperative Substitution of Albumin Deficiency Reduce Postoperative Complications?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Postoperative complications assessed with POMS- and graded with Clavien-Dindo-Score
研究概览
简要总结
Aim of this study is to reduce postoperative complications (assessed by POMS-Score and graded by Clavien-Dindo-Score) by substitution of perioperative hypoalbuminaemia in high-risk patients or patients undergoing high risk surgery.
详细描述
Perioperative hypoalbuminaemia is a common condition in high risk surgery and in high risk patients. It is associated with increased morbidity and mortality. Although many studies investigated albumin substitution in critically ill patients there is still no clear recommendation for its use over any other colloid. Except for some smaller studies especially in the setting of cardiac surgery the effect of perioperative albumin substitution has not been studied yet.
This study is designed to investigate the effect of perioperative albumin substitution in high risk patients or patients undergoing high risk surgery on postoperative complications assessed by the POMS-Score and graded according to severity by the Clavien-Dindo-Score.
Patients eligible for the study are informed in detail during the pre-medication visit and written informed consent will be obtained. Additionally the Quality of Recovery 9 Score (QoR-9) will be determined. During induction of anesthesia blood is taken from every patient and the serum albumin level is determined. In case albumin is greater than 30 g/l albumin levels are controlled every 3 hours and one last time on admission to the postoperative anaesthesia care unit (PACU). Should the albumin level do not fall below 30 g/l over the whole period the patient is not randomized.
Patients with albumin ≤30g/l will be randomized using a web-based computer-generated randomization list into one of two groups:
Group human albumin (HA):
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 (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
- •age: 18 years or older
- •written informed consent
- •ASA state 3 and 4 OR
- •elective high risk surgery (open aortic surgery, open leg revascularization, thrombectomy, oesophagectomy, pancreatic surgery, cystectomy, liver surgery, change of knee- or hip-prothesis, amputation)
排除标准
- •emergency surgery
- •severe liver cirrhosis (child pugh C)
- •need for dialysis
- •patients already included in SUPERADD
- •patients with a legal representative
- •contraindications for human albumin: hypersensitivity for human albumin or any substance included in the preparation
- •pregnancy
- •breastfeeding women
- •ASA state 5
- •BMI > 35 kg/m2
研究组 & 干预措施
Human albumin
Substitution of human albumin until serum albumin >30g/l; dosage: (30 g/l - serum albumin [g/l] ) x 0,04 l/kg x body weight [kg] x 2
干预措施: Human albumin (Drug)
结局指标
主要结局
Postoperative complications assessed with POMS- and graded with Clavien-Dindo-Score
时间窗: 15 days
Postoperative complications will be detected using the POMS score. The severity of the complications will be graded with the Clavien-Dindo-Score. A complication will be regarded as clinical relevant when it is graded Clavien-Dindo-Score 2 or higher on at least one of the four days examined.
次要结局
- Length of hospital stay(until discharge from hospital, up to 6 month)
- Length of stay in postoperative anaesthesia care unit(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Length of stay in intensive care unit(until discharge from intensive care unit, up to 1 month)
- Long term mortality (6 month)(6 month)
- Short term mortality (hospital mortality)(until discharge from hospital, up to 6 month)
- Acute kidney injury(until discharge from hospital, up to 6 month)
- Quality of Recovery 9 Score(6 month after surgery)
- Amount of volume infused(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Dosage of catecholamines(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Number of red packed cells transfused(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Number of platelet concentrates transfused(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Amount of coagulation factors infused(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Intra- and postoperative Hypotension(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Incidence of pulmonal venous congestion(until discharge from postoperative anaesthesia care unit, up to 24 hours)
- Therapy with diuretics(until discharge from hospital, up to 6 month)
- Efficacy of albumin treatment(until discharge from hospital, up to 6 month)