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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-10-31

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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standard fluid regimen group

perioperative fluid treatment

Group Type ACTIVE_COMPARATOR

perioperative fluid treatment

Intervention Type BEHAVIORAL

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

restricted fluid regimen group

perioperative fluid treatment

Group Type EXPERIMENTAL

perioperative fluid management

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No