Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery- A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Postoperative length of Stay (LOS) in hospital in days
研究概览
简要总结
This is a single center prospective randomized controlled study comparing the postoperative outcome after cytoreductive surgery in ovarian cancer patient after using restrictive or individualized goal-directed fluid replacement strategy (GDT). Aim of this study will be to test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer cytoreductive surgery:
- reduces the postoperative length of hospital stay,
- cost-effective,
- GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration.
- GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate postoperative morbidity.
Intra-operatively fluid of choice in both groups will be lactate-free crystalloid at 1.0 ml/kg/h for maintenance and gelofusine for fluid bolus of 3ml/kg over 5 minutes. In group C intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim will be to maintain MAP > 65 mmHg, CVP 8-12 cm H2O and urine output > 0.5 ml/kg/h. In group G intraoperative fluid therapy will be targeted to SVV <13%, SVI > 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 in addition to clinical parameters like MAP, CVP and urine output.
Primary outcome will be length of hospital stay (LOS). Secondary outcomes will be cost of surgical treatment episode (admission till fit to discharge), postoperative morbidity survey (POMS) and 30 day morbidity and mortality.
详细描述
Aims & objectives:
The purpose of the study is to test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer cytoreductive surgery -
- Reduces the postoperative length of hospital stay.
- GDT is more cost-effective.
- GDT will be more beneficial in cases of PDS compared to IDS.
- GDT reduces postoperative morbidity.
Justification for study:
Cytoreductive surgery in ovarian cancer is usually associated with significant fluid shift attributable to suboptimal nutritional status, prolonged preoperative starvation, intraoperative blood and fluid loss, pharmacological vasodilation by neuraxial (epidural) and systemic anaesthetic drugs, intraoperative evaporative loss and the vasodilation due to systemic inflammatory response to surgery (SIRS), which was comparatively more in case of ovarian surgery. This results in hypotension and altered hemodynamics in the intra-operative and immediate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cytoreductive surgery for ovarian cancer-
- •PDS: primary (chemo-naïve patients including completion staging/ primary debulking and secondary cytoreduction)
- •IDS: interval debulking surgery (after chemotherapy)
- •American Society of Anesthesiology (ASA-PS) score of 1 - 3
- •Age more than 18 years and less than 65 years
- •Surgery of duration more than 240 minutes
- •Presumed blood loss more than 500 ml
- •Elective surgery
排除标准
- •Patient refusal
- •Inability to give consent
- •Laparoscopic surgery, Emergency surgery, patients undergoing HIPEC
- •Age younger than 18 years & more than 65 yrs, BMI > 40
- •Patients with LVEF < 30%, Arrhythmia, Acute MI (within 30 days)
- •COPD with FEV1 < 50%
- •Coagulopathy (platelet <50000/μL, aPTT > x2 control, INR >1.5)
- •Significant liver dysfunction (liver enzymes >x3 times normal)
- •Significant renal dysfunction (creatinine >x2 times normal)
- •Psychiatric disorders
- •Sepsis or SIRS
- •Hypersensitivity to Gelofusine
结局指标
主要结局
Postoperative length of Stay (LOS) in hospital in days
时间窗: through study completion, an average of 2 years
From day of surgery to the day of fit to discharge
次要结局
- Post operative morbidity survey (POMS survey)(on 1,3,5 and 7th postoperative day and through study completion, an average of 2 years)
- Cost of treatment(through study completion, an average of 2 years)
- 30 day morbidity and mortality(through study completion, an average of 2 years)