NL-OMON40837撤回不适用
Intestinal microvascular alterations and cytokine kinetics following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy - MACH-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Patients > 18 years of age
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Undergoing a CS-HIPEC procedure for colorectal carcinoma
- •Chemotherapeutic agent used for HIPEC is Mitomycin-C
- •Signed informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •* Age <18 years
- •* Atrial fibrillation (because of possible interference with FloTrac*/Vigileo* cardiac output monitor)
- •* Left ventricular ejection fraction *30%
- •* Serious pulmonary disease (resting pO2 <90% at room air)
- •* Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
- •* Inadequate bone marrow function (ANC *1.5 x 109/L and/or platelet count * 100 x 109/L)
- •* Pre-existing liver failure (Serum bilirubin * 2 x ULN, and/or ALAT and ASAT * 3 x ULN or need for partial hepatectomy during CS
- •* History of auto-immune or chronic inflammatory disease and/or on immunomodulatory medication
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