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Clinical Trials/NCT01399814
NCT01399814
Completed
Phase 3

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

Nanjing PLA General Hospital0 sites179 target enrollmentMay 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Surgery
Sponsor
Nanjing PLA General Hospital
Enrollment
179
Primary Endpoint
clinical perioperative complications
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
October 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing PLA General Hospital

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

Outcomes

Primary Outcomes

clinical perioperative complications

Time Frame: 30 days after surgery

Secondary Outcomes

  • death(30 days after surgery)
  • adverse effects(30 days after surgery)

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