Ireland
--:--IST
Recruiting Observational

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

NCT06475261 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-27
Last updated
2025-03-07

Condition(s) studied

Oxygen DeficiencyAcute Kidney InjuryOvarian Carcinoma

Investigational drug(s) / intervention(s)

Tissue Oximetry with ForeSight

Tissue Oximetry with ForeSight: Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer

Study summary

Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy.

The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * American Society Anesthesiologists (ASA) Classification 1-2 * Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy. Exclusion Criteria: * Age \< 18 years * ASA \> or = 3 * Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy

Primary outcome measure(s)

  • Correlation between intraoperative tissue oximetry and postoperative acute renal injury. — Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.
    An intraoperative mean tissue oximetry value of 65% or less is considered to predict cellular damage. Postoperative renal injury is classified according to AKIN and KIDGO criteria.

Trial sites (1)

FacilityCityRegionStatus
Policlinico "A. Gemelli" IRCCS Rome Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06475261 on ClinicalTrials.gov ↗ ← All trials in Italy