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

Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399814
• Other study ID #: 2009NLY031
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2011
• Last updated: July 21, 2011
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2009
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Immunization
• Perioperative Care
• Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical perioperative complications		30 days after surgery	Yes
Secondary	death		30 days after surgery	Yes
Secondary	adverse effects	ischemia and impairment of renal function	30 days after surgery	Yes