Policlinico "A. Gemelli" IRCCS
Rome, Italy
Location status: Recruiting
Location contact
Stefano Catarci, MD
CONTACT
Stefano Catarci, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06475261
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.
Interested in participating?
Request Info18 year–75 year
Female
Observational
Rome, Italy
Location status: Recruiting
Stefano Catarci, MD
CONTACT
Stefano Catarci, MD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer
Other names: Hemodynamics parameters with Hemosphere
Time frame: 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.
Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.
Describing intraoperative variation of tissue oximetry expressed in percent.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From 1st to 7th postoperative days
Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL
Time frame: 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
Time frame: From 1st to 7th postoperative day
Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Time frame: From 1st to 7th postoperative day
Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Time frame: From 1st to 7th postoperative day
Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L
Time frame: From 1st to 7th postoperative day
Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
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