NCT01703442撤回不适用
Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Exact measurement of urine production
研究概览
简要总结
A single-center prospective observational study. This study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome.
Primary hypothesis:
• Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are phases of temporary anuria.
Secondary hypothesis:
- Perioperative anuric phases are directly associated to the postoperative increase of NGAL (neutrophil gelatinase-associated lipocalin) and creatinine
- Perioperative renal dysfunction is directly associated to postoperative complications and functional recovery of patients
- A response of urine flow to a standardized postoperative diuretic bolus can identify patients who benefit from a pharmaceutical fluid mobilization
- Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the methods for the measurement of stroke volume of the heart differ
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Offered patient information and written informed consent
- •Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour
排除标准
- •Patients with relapse Ovarian Cancer
- •Patients aged less than 18 years
- •Persons without the capacity to consent
- •Unability of German language use
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •(Unclear) history of alcohol or substances disabuse
- •Coworker of the Charité
- •Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalisation
- •Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
- •Neurological or psychiatric disease at the beginning of hospitalisation
- •CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalisation
- •American Society of Anaesthesiologists (ASA) classification greater than IV
- •Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation
- •Pulmonal oedema in thorax x-ray at the beginning of hospitalisation
- •History of intracranial hemorrhage within one year before participation in the study
- •Conditions following venous thrombosis within the last three years before study inclusion
- •Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
- •Diabetes mellitus with signs of severe neuropathy
结局指标
主要结局
Exact measurement of urine production
时间窗: During the operation and in the 72-hour postoperative sample period
Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)
次要结局
- Exact measurement of urine production(During the operation and in the 72-hour postoperative sample period)
- Depth of Anesthesia(During the operation)
- Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine(During the operation and in the 72-hour postoperative sample period)
- Quality of life and functional status(Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks)
- Hemodynamic parameters(During the operation)
- Blood loss(During the operation)
- Organ dysfunctions(During the operation and in the 72-hour postoperative sample period)
- Duration until fulfilment of hospital discharge criteria(Participants will be followed for the duration of an expected average of 4 weeks)
- Amount of vasopressors(During the operation and in the 72-hour postoperative sample period)
- Postoperative pain(In the 72-hour postoperative sample period)
- ICU and hospital length of stay(Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks)
- Body weight development(In the 72-hour postoperative sample period)
- Inflammatory parameters(In the 72-hour postoperative sample period)
研究者
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
Charite University, Berlin, Germany
研究点 (1)
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