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

Recruiting

• Conditions: Oxygen Deficiency; Acute Kidney Injury; Ovarian Carcinoma

• Registration Number: NCT06475261
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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 Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Study Start: 2024-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico "A. Gemelli" IRCCS; 🇮🇹 Rome, Italy