Clinical trial · Interventional
Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery
Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery- A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \<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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EV1000(FloTrac System 4.0) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group (Group C)
- description
- Conventional Fluid therapy guided by clinical parameter Intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim to maintain MAP \> 65 mmHg, CVP 8-12 cm H2O and urine output \> 0.5 ml/kg/h.
- type
- ACTIVE_COMPARATOR
- label
- Goal directed group (Group G)
- description
- Intervention: Machine guided fluid therapy using EV1000 (FloTrac System 4.0 Edward Lifesciences, Irvine, CA, USA) Intraoperative fluid therapy will be targeted to SVV \<13%, SVI \> 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 using EV1000 floTrac monitor in addition to clinical parameters like MAP, CVP and urine output
- interventionNames
- Device: EV1000(FloTrac System 4.0)
Primary outcomes (1)
- measure
- Postoperative length of Stay (LOS) in hospital in days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- BACKGROUNDMcKenny M, Conroy P, Wong A, Farren M, Gleeson N, Walsh C, O'Malley C, Dowd N. A randomised prospective trial of intra-operative oesophageal Doppler-guided fluid administration in major gynaecological surgery. Anaesthesia. 2013 Dec;68(12):1224-31. doi: 10.1111/anae.12355. Epub 2013 Sep 30. PMID 24116747
- BACKGROUNDChattopadhyay S, Mittal S, Christian S, Terblanche AL, Patel A, Biliatis I, Kucukmetin A, Naik R, Galaal K. The role of intraoperative fluid optimization using the esophageal Doppler in advanced gynecological cancer: early postoperative recovery and fitness for discharge. Int J Gynecol Cancer. 2013 Jan;23(1):199-207. doi: 10.1097/IGC.0b013e3182752372. PMID 23154265
- BACKGROUNDBennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050. PMID 10439777