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

NCT03519165 | Completed DMC

• 1 other identifier: EC/TMC/56/15
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.reduces the postoperative length of hospital stay,
2. 2.cost-effective,
3. 3.GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration.
4. 4.GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate postoperative morbidity.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; goal-directed fluid therapy; SVV

Outcome Measures

Primary Outcomes (1)

• Postoperative length of Stay (LOS) in hospital in days

  From day of surgery to the day of fit to discharge

  through study completion, an average of 2 years

Secondary Outcomes (3)

• Cost of treatment

  through study completion, an average of 2 years

• Post operative morbidity survey (POMS survey)

  on 1,3,5 and 7th postoperative day and through study completion, an average of 2 years

• 30 day morbidity and mortality

  through study completion, an average of 2 years

Study Arms (2)

Control group (Group C)

NO INTERVENTION

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.

Goal directed group (Group G)

ACTIVE COMPARATOR

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

Device: EV1000(FloTrac System 4.0)

Interventions

EV1000(FloTrac System 4.0) DEVICE

Goal directed group (Group G)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Centre

Kolkata, West Bengal, 700156, India

Location

Related Publications (3)

• McKenny 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 BACKGROUND

• Chattopadhyay 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 BACKGROUND

• Bennett-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 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jyotsna Goswami, MD

  Tata Medical Center

  PRINCIPAL INVESTIGATOR

• Asima Mukhopadhyay, MD, PHD

  Tata Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Flotrac System 4.0 Edwards Lifesciences, Irvine, CA, USA

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 8, 2018
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

IN (1)