A double-blind non inferiority clinical trial to compare the nephroprotection of cilastatn versus thiosulfate in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of patients with renal failure at 7 days* (if there is renal damage, follow-up until postoperative day 14) measured through creatinine values and the KDIGO classification. Renal failure is defined as an increase in serum creatinine of 1.5 to 1.9 times baseline, or an increase in serum creatinine by #0.3 mg/dL (#26.5 μmol/L), or a decrease in urine output <0.5 mL/kg/hour for 6 to 12 hours.
研究概览
简要总结
Non inferiority study of cilastatin versus Thiosulfate in reducing acute kidney damage (days 1-7) (creatinine levels and KDIGO scale) in patients treated with CRS+HIPEC-cisplatin during the immediate postoperative period.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age: adult patients from 18-75 years
- •Sex: Male/Female
- •Eastern Cooperative Oncology Group Performance status (ECOG PS) # 2
- •General situation of the patient: patient suitable for major surgery, with values of creatinine, bilirubin, blood series in a range close to normal (Hb>10g/dl, leucos >3000/ml, neutrals >1000/ml, platelets >100,000 /ml).
- •Patients evaluated in the Anesthesia office and considered suitable for the intervention
- •Signed informed consent
- •Disease confined to the abdomen: CRS+HIPEC is not contemplated in patients with lung or bone metastases, etc.
- •Evaluation in a Multidisciplinary Committee: radiological PCI is performed and it is estimated possibilities of complete cytoreduction, indicating CRS + HIPEC.
排除标准
- •Non-acceptance to participate in the clinical trial.
- •Not suitable for major surgery.
- •Disease not limited to the abdomen or with signs that it cannot be optimally cytoreduced (intestinal obstruction, biliary obstruction, ureteral obstruction, diffuse involvement of the small intestine or mesentery).
- •Allergy to platinum.
- •Patients with a neurological history who in the investigator's opinion are at risk of seizures associated with imipenem/cliastatin treatment.
结局指标
主要结局
Percentage of patients with renal failure at 7 days* (if there is renal damage, follow-up until postoperative day 14) measured through creatinine values and the KDIGO classification. Renal failure is defined as an increase in serum creatinine of 1.5 to 1.9 times baseline, or an increase in serum creatinine by #0.3 mg/dL (#26.5 μmol/L), or a decrease in urine output <0.5 mL/kg/hour for 6 to 12 hours.
Percentage of patients with renal failure at 7 days* (if there is renal damage, follow-up until postoperative day 14) measured through creatinine values and the KDIGO classification. Renal failure is defined as an increase in serum creatinine of 1.5 to 1.9 times baseline, or an increase in serum creatinine by #0.3 mg/dL (#26.5 μmol/L), or a decrease in urine output <0.5 mL/kg/hour for 6 to 12 hours.
次要结局
- Differences in plasma pharmacokinetic variables of cisplatin during the HIPEC procedure between cilastatin-treated and thiosulfate-treated patients
- Percentage of patients experiencing serious adverse events, adverse events related to study treatment, and adverse events occurring during the study.
- Comparison of ARF in patients with cilastatin or thiosulfate with a total follow-up of 14 days
- Comparison of urinary H202 values between patients who suffer from DR and patients who do not suffer from it.
- Comparison of urinary H202 values between patients who suffer DR and patients who do not.
- Comparison of preoperative, intraoperative and postoperative factors between patients who suffer from kidney damage and patients who do not.
- Comparison of urinary FasL between patients with renal damage and patients without.
研究者
Maria Carmen de la Cruz Arguedas
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon