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

Primary Purpose

Surgery, Perioperative Care, Immunization

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

perioperative fluid management

perioperative fluid treatment

About this trial

This is an interventional treatment trial for Surgery

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard fluid regimen group

restricted fluid regimen group

Arm Description

perioperative fluid treatment

Outcomes

Primary Outcome Measures

clinical perioperative complications

Secondary Outcome Measures

death

adverse effects

ischemia and impairment of renal function

Full Information

NCT ID

NCT01399814

First Posted

July 18, 2011

Last Updated

July 21, 2011

Sponsor

Nanjing PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01399814

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing PLA General Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgery, Perioperative Care, Immunization, Abdominal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard fluid regimen group

Arm Type

Active Comparator

Arm Description

perioperative fluid treatment

Arm Title

restricted fluid regimen group

Arm Type

Experimental

Arm Description

perioperative fluid treatment

Intervention Type

Behavioral

Intervention Name(s)

perioperative fluid management

Intervention Description

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

Intervention Name(s)

perioperative fluid treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical perioperative complications

Time Frame

30 days after surgery

Secondary Outcome Measure Information:

Title

death

Time Frame

30 days after surgery

Title

adverse effects

Description

ischemia and impairment of renal function

Time Frame

30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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