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

July 18, 2011
July 21, 2011
May 2009
October 2010   (final data collection date for primary outcome measure)
clinical perioperative complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01399814 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer
Not Provided

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Surgery
  • Perioperative Care
  • Immunization
  • Abdominal Neoplasms
  • 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
  • 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
  • Active Comparator: standard fluid regimen group
    perioperative fluid treatment
    Intervention: Behavioral: perioperative fluid treatment
  • Experimental: restricted fluid regimen group
    perioperative fluid treatment
    Intervention: Behavioral: perioperative fluid management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01399814
2009NLY031
No
Yu Wen Kui, Nanjing PLA General Hospital
Nanjing PLA General Hospital
Not Provided
Not Provided
Nanjing PLA General Hospital
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP