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

Study Overview
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Brief Summary
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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
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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
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Surgery, Perioperative Care, Immunization, Abdominal Neoplasms

Intervention / Treatment
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* Behavioral: perioperative fluid management
* Behavioral: perioperative fluid treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were considered eligible if they had no life-threatening systemic disease (ASA groups 1 3) Exclusion Criteria: lactation mental disorders language problems smoking within two weeks diabetes mellitus renal insufficiency disseminated cancer secondary cancers inflammatory bowel disease, or diseases hindering epidural analgesia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard fluid regimen group<br>perioperative fluid treatment | Behavioral: perioperative fluid treatment<br>* 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<br>|
| Experimental: restricted fluid regimen group<br>perioperative fluid treatment | Behavioral: perioperative fluid management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical perioperative complications |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 30 days after surgery | 
| adverse effects | ischemia and impairment of renal function | 30 days after surgery |