Trial Information
Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
Inclusion Criteria:
- Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal
chemotherapy
Exclusion Criteria:
- Patients under the age of 18, patients with hemodynamically significant aortic
regurgitation and heart rhythm disorders
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
rate of abdominal complications
Outcome Time Frame:
90 day postoperative complication
Safety Issue:
No
Principal Investigator
Ester Forastiere, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Regina Elena CI
Authority:
Italy: AIFA ("Agenzia italiana per il farmaco")
Study ID:
89/10
NCT ID:
NCT01882920
Start Date:
June 2010
Completion Date:
September 2012
Related Keywords:
- Primary Peritoneal Neoplasm
- Secondary Peritoneal Neoplasm
- Cytoreductive surgery
- hyperthermic intraperitoneal chemotherapy
- Goal directed fluid therapy
- Neoplasms
- Fever
- Peritoneal Neoplasms