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

Sponsor

Nanjing PLA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01399814

Collaborator

(none)

179

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Perioperative Care Immunization Abdominal Neoplasms	Behavioral: perioperative fluid management Behavioral: perioperative fluid treatment	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard fluid regimen group perioperative fluid treatment	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
Experimental: restricted fluid regimen group 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

Arm

Intervention/Treatment

Active Comparator: standard fluid regimen group

perioperative fluid treatment

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

Experimental: restricted fluid regimen group

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

Outcome Measures

Primary Outcome Measures

clinical perioperative complications [30 days after surgery]

Secondary Outcome Measures

death [30 days after surgery]
adverse effects [30 days after surgery]
ischemia and impairment of renal function

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanjing PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01399814

Other Study ID Numbers:

2009NLY031

First Posted:

Jul 22, 2011

Last Update Posted:

Jul 22, 2011

Last Verified:

May 1, 2009

Additional relevant MeSH terms:

Abdominal Neoplasms

Study Results

No Results Posted as of Jul 22, 2011