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

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Oxygen Deficiency; Ovarian Carcinoma
• Intervention / Treatment: Device: Tissue Oximetry with ForeSight

Detailed Description

Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidney's tissue oxygenation.

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

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 (according to the AKIN and KIDGO classification) in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.

Secondary objectives are:

• describe the variation in muscle tissue oximetry and hemodynamic parameters (systolic, mean, diastolic blood pressure) during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy .
• describe the variation in renal function values (blood urea nitrogen, creatinine) and serum electrolytes (sodium, potassium, chloremia, calcemia) in the post-operative period (from the first to the seventh postoperative day).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Stefano Catarci, MD; Phone Number: 0630153744; Email: stefano.catarci@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Policlinico "A. Gemelli" IRCCS
    • Contact: Stefano Catarci, MD; Phone Number: 06 3015 3744; Email: stefano.catarci@policlinicogemelli.it
    • Principal Investigator: Stefano Catarci, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue oximetry	Describing intraoperative variation of tissue oximetry expressed in percent.	TWA value resulted by intraoperative values recorded every 20 minutes during surgery.
Tissue oximetry during hyperthermic intraperitoneal chemotherapy	Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.	TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .
Emodinamic parameters (systolic, mean and diastolic pressures)	Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg	Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.
Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy	Describing mean values of arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg, during hyperthermic intraperitoneal chemotherapy	A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy
Serum Creatinine level	Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL	From 1st to 7th postoperative days
Serum Blood urea nitrogen level	Mean value of Serum blood urea nitrogen, daily assessed for the first 7 postoperative days, expressed in mg/dL	From 1st to 7th postoperative day
Serum sodium level	Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L	From 1st to 7th postoperative day
Serum Potassium level	Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L	From 1st to 7th postoperative day
Serum Chloride level	Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L	From 1st to 7th postoperative day
Serum Calcium level	Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L	From 1st to 7th postoperative day

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefano Catarci, MD, FPG IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Hyperthermic Intraperitoneal Chemotherapy; Tissue Oximetry; Hemodynamics parameters
• Additional Relevant MeSH Terms: Urogenital Diseases; Wounds and Injuries; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Signs and Symptoms, Respiratory; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Acute Kidney Injury; Hypoxia; Fever
• Other Study ID Numbers: 6702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No