Идёт набор NCT06475261

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

— Наблюдательное Oxygen Deficiency Acute Kidney Injury Ovarian Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tissue Oximetry with ForeSight.
Кому может быть актуально: Состояния в реестре: Oxygen Deficiency, Acute Kidney Injury, Ovarian Carcinoma. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device

Обзор

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.

Подробное описание

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).

Вмешательства

Устройство 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

Первичные конечные точки

Correlation between intraoperative tissue oximetry and postoperative acute renal injury. [Срок оценки: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.]

Вторичные конечные точки (10)

Tissue oximetry [Срок оценки: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.]
Tissue oximetry during hyperthermic intraperitoneal chemotherapy [Срок оценки: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .]
Emodinamic parameters (systolic, mean and diastolic pressures) [Срок оценки: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.]
Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy [Срок оценки: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy]
Serum Creatinine level [Срок оценки: From 1st to 7th postoperative days]
Serum Blood urea nitrogen level [Срок оценки: From 1st to 7th postoperative day]
Serum sodium level [Срок оценки: From 1st to 7th postoperative day]
Serum Potassium level [Срок оценки: From 1st to 7th postoperative day]
Serum Chloride level [Срок оценки: From 1st to 7th postoperative day]
Serum Calcium level [Срок оценки: From 1st to 7th postoperative day]

Критерии участия

Критерии включения

American Society Anesthesiologists (ASA) Classification 1-2
Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.