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Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery

Tata Medical Center · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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naovarian-cancer
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: 1. reduces the postoperative length of hospital stay, 2. cost-effective, 3. GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration. 4. 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 \ 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.
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