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

This study has been completed.
Sponsor:
Information provided by:
Nanjing PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01399814
First received: July 18, 2011
Last updated: July 21, 2011
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Surgery
Perioperative Care
Immunization
Abdominal Neoplasms
 Behavioral: perioperative fluid management
Behavioral: perioperative fluid treatment
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Nanjing PLA General Hospital:

Primary Outcome Measures:
  • clinical perioperative complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • adverse effects [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
    ischemia and impairment of renal function


Enrollment: 179
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yu Wen Kui, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT01399814     History of Changes
Other Study ID Numbers: 2009NLY031
Study First Received: July 18, 2011
Last Updated: July 21, 2011
Health Authority: China: National Natural Science Foundation

Additional relevant MeSH terms:
Abdominal Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013