Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
NCT Number: NCT06475261
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Oxygen Deficiency|Acute Kidney Injury|Ovarian Carcinoma
Interventions: DEVICE: Tissue Oximetry with ForeSight
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-01-01

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.

Primary Outcome Measures: 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 value resulted by values recorded intraoperatively every 20 minutes.
Secondary Outcome Measures: Tissue oximetry, Describing intraoperative variation of tissue oximetry expressed in %, TWA value resulted by intraoperative values recorded every 20 minutes during surgery.|Tissue oximetry, Describing intraoperative variation of tissue oximetry expressed in %, TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .|Emodinamic parameters, Describing intraoperative variation of arterial pressure (systolic, mean and diastolic pressures) expressed in mmHg, Intraoperatively, a medium value resulted by values recorded every 20 minutes during surgery.|Emodinamic parameters, Describing intraoperative variation of arterial pressure (systolic, mean and diastolic pressures) expressed in mmHg, Intraoperatively, a medium value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy|Creatinine, Variation in renal function parameters daily assessed for the first 7 postoperative days, From 1st to 7th postoperative days|Blood urea nitrogen, Variation in renal function parameters daily assessed for the first 7 postoperative days, From 1st to 7th postoperative day|Sodium, Variation in serum electrolytes daily assessed for the first 7 postoperative days, From 1st to 7th postoperative day|Potassium, Variation in serum electrolytes daily assessed for the first 7 postoperative days, From 1st to 7th postoperative day|Chloremia, Variation in serum electrolytes daily assessed for the first 7 postoperative days, From 1st to 7th postoperative day|Calcemia, Variation in serum electrolytes daily assessed for the first 7 postoperative days, From 1st to 7th postoperative day