EUCTR2008-006135-12-DE进行中（未招募）不适用
Balanced crystalloids versus balanced colloids within a goal-directed hemodynamic protocol in patients undergoing gynaecological tumor resection.Balancierte Kristalloide versus balancierte Kolloide im Rahmen eines zielgerichteten Hämodynamik-Protokolls bei Patientinnen zur gynäkologischen Tumoroperation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Offered patient information and written informed consent
- •No participation in another trial according to the German Drug Law at the study inclusion, during the study and not planned until the 10 th day postoperative
- •Female Patients with metastatic ovarian carcinoma , who want to undergo a tumor reduction operation in the Universitätsklinik, Campus Virchow-Klinikum of the Charité – University Medicine Berlin
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age less than 18 years old
- •Pregnancy or lactation
- •Lacking willingness to save and hand out pseudonymised data within the study
- •Accommodation in an institution due to an official or judicial order
- •Advanced disease of the oesophagus of nasopharyngeal cavity
- •Operations in the area of the oesophagus or nasopharynx within the last two months
- •Liver disease (Child B or C cirrhosis, End-Stage Liver Disease [MELD] score greater than 10)
- •Conditions after acute or chronic pancreatitis
- •History of bleeding tendency
- •Von Willebrands disease
- •Neurological or psychiatric disease
- •Unclear history of alcoholism
- •Chronic heart failure class IV according to the New York Heart Association (NYHA)
- •American Society of Anaesthesiologists (ASA) classification greater than III
- •Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
- •Existence of a pulmonary oedema in the preoperative chest x-ray
- •Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
- •History of intracranial haemorrhage within one year before participation in the study
- •Hyperkalaemia > 5,8 mmol / l and Hypernatriaemia > 155 mmol / l
- •Praeoperative ileus symptomatology
- •Known history of hypermagnesaemia
- •Known history of metabolic alkalosis
- •Derailed Diabetes mellitus (Glucose > 300 mg/dl) before inclusion
研究者
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Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resectioISRCTN53154834Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)50
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