MedTrace Logo

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

NCT03519165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2020-01-31

No results posted yet for this study

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. 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

Interventions

DEVICE

EV1000(FloTrac System 4.0)

Sponsors & Collaborators

  • Tata Medical Center

    lead OTHER

Principal Investigators

  • Jyotsna Goswami, MD · Tata Medical Center

  • Asima Mukhopadhyay, MD, PHD · Tata Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519165 on ClinicalTrials.gov