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

Phase 3

Completed

• Conditions: Surgery; Perioperative Care; Immunization; Abdominal Neoplasms
• Interventions: Behavioral: perioperative fluid treatment; Behavioral: perioperative fluid management

• Registration Number: NCT01399814
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-05
• Study Start: 2009-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard fluid regimen group	perioperative fluid treatment	perioperative fluid treatment
restricted fluid regimen group	perioperative fluid management	perioperative fluid treatment

Primary Outcome Measures

Name	Time	Method
clinical perioperative complications	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
death	30 days after surgery
adverse effects	30 days after surgery	ischemia and impairment of renal function