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临床试验/NCT01882218
NCT01882218撤回4 期

A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer

University of Louisville2 个研究点 分布在 1 个国家开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Morbidity

研究概览

简要总结

The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

详细描述

Our study will focus on 108 patients requiring hepatic resection for colorectal cancer metastasis or primary hepatocellular carcinoma. These patients will then be randomized into two 54 patient arms: the control arm of conventional resuscitation only and the experimental arm of conventional resuscitation with DPR immediately post operatively. Patient exclusion criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18 years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart failure, 4) patients requiring portal venous embolization prior to resection, or 5) women who are pregnant or lactating/breast feeding. A pregnancy test (urine or blood) will be done for female subjects of child bearing potential the day prior or the morning of surgery per the usual standard of care pre-op labs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal cancer
  • Scheduled for liver resection

排除标准

  • Chronic renal failure
  • Cirrhosis
  • Congestive heart failure
  • Requiring portal venous embolization prior to resection
  • Pregnant or nursing

研究组 & 干预措施

Standard treatment

Active Comparator

Standard liver surgery and post-operative treatment

干预措施: Standard Treatment (Drug)

Galactose

Experimental

Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.

干预措施: Galactose (Drug)

结局指标

主要结局

Morbidity

时间窗: Six months

次要结局

  • Cytokine levels(Six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Smith

MD

University of Louisville

研究点 (2)

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