ISRCTN53154834已完成4 期
Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resection: a prospective, randomised, controlled, double-blinded, two-armed single-centre trial
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 个研究点目标入组 50 人开始时间: 2009年8月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female patients aged 18 and over
- •2. Patients with metastatic ovarian carcinoma undergoing a tumour reduction operation at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin
- •3. Offered patient information and written informed consent
- •4. No participation in another clinical trial during the trial until the 10th post-operative day
排除标准
- •1. Aged less than 18 years
- •2. Pregnancy or lactation
- •3. Lacking willingness to save and hand out pseudonymised data within the clinical study
- •4. Accommodation in an institution due to an official or judicial order
- •5. Advanced disease of the oesophagus of nasopharyngeal cavity
- •6. Operations in the area of the oesophagus or nasopharynx within the last two months
- •7. Liver disease (Child B or C cirrhosis, end-stage liver disease [MELD] score greater than 10)
- •8. Conditions after acute or chronic pancreatitis
- •9. History of bleeding tendency, e.g. Von Willebrands disease
- •10. Neurological or psychiatric disease
- •11. Unclear history of alcohol related disorder
- •12. Chronic heart failure class IV according to the New York Heart Association (NYHA)
- •13. American Society of Anaesthesiologists (ASA) classification greater than III
- •14. Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
- •15. Existence of a pulmonary oedema in the pre-operative chest x-ray
- •16. Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
- •17. History of intracranial haemorrhage within one year before participation in the study
- •18. Hyperkalaemia greater than 5.8 mmol/l and hypernatriaemia greater than 155 mmol/l
- •19. Pre-operative ileus symptomatology
- •20. Known history of hypermagnesaemia
- •21. Known history of metabolic alkalosis
- •22. Derailed diabetes mellitus (glucose greater than 300 mg/dl) before inclusion
研究者
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