Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society Anesthesiologists (ASA) Classification 1-2
- •Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.
排除标准
- •Age < 18 years
- •ASA > or = 3
- •Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy
结局指标
主要结局
Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
时间窗: 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.
次要结局
- Tissue oximetry(TWA value resulted by intraoperative values recorded every 20 minutes during surgery.)
- Tissue oximetry during hyperthermic intraperitoneal chemotherapy(TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .)
- Emodinamic parameters (systolic, mean and diastolic pressures)(Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.)
- Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy(A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy)
- Serum Blood urea nitrogen level(From 1st to 7th postoperative day)
- Serum sodium level(From 1st to 7th postoperative day)
- Serum Creatinine level(From 1st to 7th postoperative days)
- Serum Potassium level(From 1st to 7th postoperative day)
- Serum Chloride level(From 1st to 7th postoperative day)
- Serum Calcium level(From 1st to 7th postoperative day)