Clinical trial NCT06475261: Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Official title: Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oxygen Deficiency
Acute Kidney Injury
Ovarian Carcinoma
Keywords: Tissue Oximetry
Hyperthermic Intraperitoneal Chemotherapy
Acute Kidney Injury
Hemodynamics parameters
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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 outcomes:
measure: Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
timeFrame: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.
Secondary outcomes:
measure: Tissue oximetry
timeFrame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.
measure: Tissue oximetry during hyperthermic intraperitoneal chemotherapy
timeFrame: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .
measure: Emodinamic parameters (systolic, mean and diastolic pressures)
timeFrame: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.
measure: Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy
timeFrame: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy
measure: Serum Creatinine level
timeFrame: From 1st to 7th postoperative days
measure: Serum Blood urea nitrogen level
timeFrame: From 1st to 7th postoperative day
measure: Serum sodium level
timeFrame: From 1st to 7th postoperative day
measure: Serum Potassium level
timeFrame: From 1st to 7th postoperative day
measure: Serum Chloride level
timeFrame: From 1st to 7th postoperative day
measure: Serum Calcium level
timeFrame: From 1st to 7th postoperative day
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico "A. Gemelli" IRCCS
Study officials:
affiliation: FPG IRCCS
name: Stefano Catarci, MD
role: PRINCIPAL_INVESTIGATOR
References: