2024-510943-76-00招募中3 期
ALBU-CHIP - Efficacy of human 20% albumin solution + Ringer Lactate versus Ringer Lactate for fluid replacement strategy during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy : a randomized clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Comprehensive Complication Index (CCI score) at day 28
研究概览
简要总结
To assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 years old and older
- •Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- •Patient volunteer for the study and provided written informed consent
- •Patient affiliated to the French Health Insurance
排除标准
- •Pre-operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition)
- •Hyperkaliemia > 6.0 mmol/L
- •Hypercalcemia > 2.60 mmol/L
- •Chronic use of digitalis and hyperkalemic diuretics
- •Pregnancy, Breast feeding
- •Aged > 75 years old
- •Functional status making the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky scale < 75)
- •Patients at high risk of intra- and post-operative pulmonary complications (atelectasis, large pleural effusions)
- •Significant ascites with preoperative respiratory impact
- •Unbalanced diabetes (HbA1c > 8.5%)
- •Recent cerebral trauma < 6 months (of traumatic, ischemic or hemorrhagic origin)
- •Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2 or need for renal replacement therapy)
- •Participation in another interventional research project or being in the exclusion period following a previous research project
- •Patient deprived of liberty
- •Patient under guardianship
- •Severe pre-operative Hypoalbuminemia (albuminemia < 20g/L)
- •Chronic heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
- •Allergy to exogen human albumin
- •Allergy to Ringer Lactate
结局指标
主要结局
Comprehensive Complication Index (CCI score) at day 28
Comprehensive Complication Index (CCI score) at day 28
次要结局
- CCI score at day 7
- volume of intra operative and post-operative (48h) post-operative fluid therapy
- cumulated incidence of surgical post-operative complications at 28 days
- cumulated incidence of infectious post-operative complications at 28 days
- cumulated incidence of medical post-operative complications at 28 days
- need for mechanical ventilation
- renal replacement therapy between surgery and day 28
- SOFA score variation between pre-operative period and 48h after surgery
- number of days alive out of intensive care unit and out of hospital until day 28
- mortality at day 28
- Hypersensitivity reactions to albumin at 133 days
研究者
Arthur MOREAU
Scientific
Assistance Publique Hopitaux De Paris
研究点 (5)
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