DRKS00000098已完成1 期
The penetration of moxifloxacin(BAY 12-8039) into the excretory pancreatic secret after intravenous application
IVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie0 个研究点目标入组 20 人开始时间: 2009年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •patients > 18 years of age with proposed elective pancreatic head resection and pancreatic jejunostomy for pancreas carcinoma, lesion of papilla Vateri or duodenum or chronic pancreatitis
- •- previous discharge of bile duct by percutaneous PTD or endoscopic discharge because of indolent icterus.
- •- PPPD or classical 'Kausch-Whipple' surgery
- •- preoperative PTD or ERCP due to obstructive cholestasis
- •- preoperative recanalisation of the portal vein or further vena because of chronic pancreatitis
- •- preoperative application of Somatostatin, Glucagon, Calcitonin, or Aprotinin
- •- reconstruction of the passage by pancreatic jejunostomy and pancreatic duct catheter
- •- available informed-consent
排除标准
- •- preoperative chemoradiotherapy
- •- preoperative radiotherapy or chemotherapy
- •- preoperative therapy with corticosteriods up to 1 week before surgery
- •- surgery in anamnesis within one week before surgery (except laparoscopic staging)
- •- preoperative liver cirrhosis Child B or C
- •- impossible operability, intraoperative change of surgical procedure
- •- extension of surgical intervention to liver resection
- •- known incompatibility to Fluorochinolons
- •- ascites and suspicion of spontaneous bacterial peritonitis
- •- pancreatic, peripancreatic sepsis or intra-abdominal infection because of pancreatitis
- •- perforated septic ulcer or traumatic (duodenal) perforation in the upper gastro-intestinal system about <24 hours
- •- traumatic perforation of the small intestine or colon about <12 hours
- •- transmural intestinal necrosis due to an acute embolic, thrombotic or mechanical occlusion
- •- infection, which requires a longer anti-infective treatment as the duration of the medication of the study; patients, who are in need of a antibiotic lavage of the abdominal cavity or the surgical wound
- •- essential 'open abdominal lavage'
- •- females with genital (gynaecological) infections
- •- planned relaparotomy
- •- known hypersensitivity towards the medication of the study
- •- pregnancy, lactation period or female, whose a pregnancy can?t excluded
- •- serious, life-threatening diseases at lifespan less than 48 hours respectively. APACHE-Score >25;
- •- Neutropenia (amount of neutophils <1000 cells / microlitre) because of cancer or chemotherapy
- •- known immunosuppressive long-term therapy (included systemic long-term treatment with >15 mg Prednisone or a Prednisone equivalent per day);
- •- HIV-seropositive patients with CD4-cells <200/microlitre or HIV-seropositive patients, who obtain HAART (Please note: a HIV-test is not required for this described study)
- •- liver cirrhosis in terminal stage (Child-Pugh C) or increase of Transaminases over the 5-fold of the upper standard value
- •- central or peripheral neuropathy (such as epilepsy or psychosis);
- •- clinical appreciable bradykardia
- •- symptomatic cardiac dysrhytmia in anamesis
- •- known congenital or sporadic QTc-extension or treatment von concomitant medication, which prolong the QTc-intervall (such as Cisaprid, anti-arrhythmics of class IA and III as Amiodaron, Sotalol, Disopyramid, Chinidin and Procainamid);
- •- disorders of the electrolyte balance, especially untreated hypokalaemia;
- •- affections of tendons under treatment with Chinolons in anamesis;
- •- previous participation to this study or treatment with study medication within the last 30 days
- •- known or assumed bacterial concomitant infection, with requires an additional systemic treatment
- •- treatment with a systemic (oral or parenteral) antibiotic agent 24 hours before the surgery.
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