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NCT Number: NCT01399814

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

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.

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Key information

Conditions

Surgery Abdominal Neoplasms Immunization Neoplasms Neoplasms by Site Perioperative Care

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perioperative fluid management

Behavioral

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

Behavioral

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 outcomes

  1. clinical perioperative complications

    Time frame: 30 days after surgery

Secondary outcomes

  1. death

    Time frame: 30 days after surgery

  2. adverse effects

    Time frame: 30 days after surgery

    ischemia and impairment of renal function

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2011
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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