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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399814
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
Information provided by:
Nanjing PLA General Hospital

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 Type : Interventional  (Clinical Trial)
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 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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

Primary Outcome Measures :
  1. clinical perioperative complications [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. death [ Time Frame: 30 days after surgery ]
  2. adverse effects [ Time Frame: 30 days after surgery ]
    ischemia and impairment of renal function

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Yu Wen Kui, Nanjing PLA General Hospital Identifier: NCT01399814     History of Changes
Other Study ID Numbers: 2009NLY031
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: May 2009

Additional relevant MeSH terms:
Abdominal Neoplasms
Neoplasms by Site