Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
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- What is being studied
- The protocol lists: Tissue Oximetry with ForeSight.
- Who it may be relevant to
- Registry conditions: Oxygen Deficiency, Acute Kidney Injury, Ovarian Carcinoma. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
Overview
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).
Interventions
- Device Tissue Oximetry with ForeSight
Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer
Primary outcome measures
- Correlation between intraoperative tissue oximetry and postoperative acute renal injury. [Time frame: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.]
Secondary outcome measures (10)
- Tissue oximetry [Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.]
- Tissue oximetry during hyperthermic intraperitoneal chemotherapy [Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .]
- Emodinamic parameters (systolic, mean and diastolic pressures) [Time frame: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.]
- Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy [Time frame: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy]
- Serum Creatinine level [Time frame: From 1st to 7th postoperative days]
- Serum Blood urea nitrogen level [Time frame: From 1st to 7th postoperative day]
- Serum sodium level [Time frame: From 1st to 7th postoperative day]
- Serum Potassium level [Time frame: From 1st to 7th postoperative day]
- Serum Chloride level [Time frame: From 1st to 7th postoperative day]
- Serum Calcium level [Time frame: From 1st to 7th 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Policlinico "A. Gemelli" IRCCS — Rome
Identifiers
NCT: NCT06475261 · 6702