A Phase 3 interventional study of perioperative fluid management and perioperative fluid treatment in Surgery, Perioperative Care and Immunization, sponsored by Nanjing PLA General Hospital. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Nanjing PLA General Hospital · Phase 3, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Abdominal Neoplasms; 18 are open to participants now.
This study's enrollment of 179 is above the median of 74 across 49 interventional studies indexed under Abdominal Neoplasms.
Browse Abdominal Neoplasms studies →Nanjing PLA General Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
perioperative fluid treatment
Behavioral: perioperative fluid treatment
perioperative fluid treatment
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
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
clinical perioperative complications
Time frame: 30 days after surgery
death
Time frame: 30 days after surgery
adverse effects
ischemia and impairment of renal function
Time frame: 30 days after surgery
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Nanjing PLA General Hospital