NCT01399814

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P25-P50 for phase_3 surgery

Timeline
Completed

Started May 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

May 1, 2009

Enrollment Period

1.4 years

First QC Date

July 18, 2011

Last Update Submit

July 21, 2011

Conditions

SurgeryPerioperative CareImmunizationAbdominal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • clinical perioperative complications

    30 days after surgery

Secondary Outcomes (2)

  • death

    30 days after surgery

  • adverse effects

    30 days after surgery

Study Arms (2)

standard fluid regimen group

ACTIVE COMPARATOR

perioperative fluid treatment

Behavioral: perioperative fluid treatment

restricted fluid regimen group

EXPERIMENTAL

perioperative fluid treatment

Behavioral: perioperative fluid management

Interventions

perioperative fluid managementBEHAVIORAL

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

restricted fluid regimen group
perioperative fluid treatmentBEHAVIORAL

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

standard fluid regimen group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 22, 2011

Study Start

May 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 22, 2011

Record last verified: 2009-05