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
Sponsored by
About this trial
This is an interventional treatment trial for Surgery
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
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
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
No
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
No
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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