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临床试验/NCT03956901
NCT03956901已完成不适用

Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
fluid management

研究概览

简要总结

The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. 112 patients who are in ASA I-II-lll risk groups included in this prospective study.

详细描述

Objectives: The first objective of the investigators's study was to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels.

The investigators's secondary purpose was to compare the effects of different fluid regimens on the postoperative kidney injury and the duration of hospital stay.

Methods: The study included 112 American Society of Anesthesiologists (ASA) grade I ,ll and lll patients, aged above 18 and undergoing elective gynecologic oncologic case . After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.

After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus cyristalloid/kolloid injection was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in LFM group, a 250-ml bolus cyristalloid/ kolloid injection was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.

In the first 24 hours after surgery, urine output, need for blood transfusion ,lokositoz,fever,stay in icu and length of hospital stay were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Gynecological oncologic cases
  • Patients over 18 years old
  • ASA 1-2-3 patients

排除标准

  • Patients with peripheral arterial disease
  • Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
  • Patients with entry MAP <65 mmHg
  • Patients with advanced renal and hepatic impairment
  • Mental retarded and non-cooperative patients
  • Patients with advanced heart failure, EF <30%
  • Patients have massive bleeding in the perioperative period, need for massive transfusion
  • Patients have acute pulmonary pathology
  • Patients with anaphylaxis who developed a blood product reaction
  • Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator

结局指标

主要结局

fluid management

时间窗: 3-4 hours

total fluid given durin operation

次要结局

未报告次要终点

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Güneş Özlem Yıldız

principal investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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