NCT01399814

Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Nanjing PLA General Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether perioperative fluid restriction influence on postoperative immunological function. And discuss the probable mechanism that fluid restriction regime effect on clinical data.

Detailed description

Perioperative fluid administration is a common therapy in clinical practice, and recent regime has a history about 50 years. Recently, clinicians found that traditional regime had some disadvantages, for example, pulmonary edema, increased cardiac load, increased body weight. And thus, perioperative fluid restriction regimen has been suggested and proved could reduce cardiopulmonary complications and mortality rates after major elective gastrointestinal surgery. Patients were divided into two groups randomly and underwent restricted fluid regimen or traditional fluid regimen. We determined the complications and immunological function in two groups, and analyzed the relationship between complications and immunological changes. Based on this we decide the probable mechanism that perioperative fluid restriction effects on complications.

Conditions

• Surgery
• Perioperative Care
• Immunization
• Abdominal Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	perioperative fluid management	No preloading of epidural analgesia,7ml/kg lactated ringer's solution was administered in first hour,and 5ml/kg.h during the following hours,and 1000ml of glucose 5% was administered on the rest of the day during operation.1000\~1500ml crystalloid was administered on the days following operation
BEHAVIORAL	perioperative fluid treatment	500 mL HAES 6% was accepted as preloading of epidural analgesia,12ml/kg.h lactated ringer's solution was administered during the operation ,and 1000ml of glucose 5% was administered on the rest of the day during operation.2000\~2500ml crystalloid was administered on the days following operation

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2011-07-22
• Last updated: 2011-07-22