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

Nanjing PLA General Hospital

Status and phase: Completed; Phase 3

Conditions: Immunization; Perioperative Care; Surgery; Abdominal Neoplasms

Treatments: Behavioral: perioperative fluid management; Behavioral: perioperative fluid treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01399814

2009NLY031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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179 participants in 2 patient groups

standard fluid regimen group

Active Comparator group

Description:

perioperative fluid treatment

Treatment:

Behavioral: perioperative fluid treatment

restricted fluid regimen group

Experimental group

Description:

perioperative fluid treatment

Treatment:

Behavioral: perioperative fluid management