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

NCT06475261 | Recruiting

• 1 other identifier: 6702
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Deficiency; Acute Kidney Injury; Ovarian Carcinoma

Keywords

Tissue Oximetry; Hyperthermic Intraperitoneal Chemotherapy; Acute Kidney Injury; Hemodynamics parameters

Outcome Measures

Primary Outcomes (1)

• Correlation between intraoperative tissue oximetry and postoperative acute renal injury.

  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.

  Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.

Secondary Outcomes (10)

• Tissue oximetry

  TWA value resulted by intraoperative values recorded every 20 minutes during surgery.

• Tissue oximetry during hyperthermic intraperitoneal chemotherapy

  TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .

• Emodinamic parameters (systolic, mean and diastolic pressures)

  Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.

• Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy

  A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy

• Serum Creatinine level

  From 1st to 7th postoperative days

Interventions

Tissue Oximetry with ForeSight DEVICE

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

Also known as: Hemodynamics parameters with Hemosphere

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy

You may qualify if:

• American Society Anesthesiologists (ASA) Classification 1-2
• Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.

You may not qualify if:

• Age \< 18 years
• ASA \> or = 3
• Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico "A. Gemelli" IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Hypoxia; Acute Kidney Injury; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Stefano Catarci, MD

  FPG IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Catarci, MD

CONTACT

0630153744; stefano.catarci@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: July 27, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)