Intraoperative Hypovolemia and Fluid Therapy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00852449
First received: February 26, 2009
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a key trigger of organ dysfunction, the purpose of this study was to compare the influence of restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and postoperative organ dysfunction.


Condition Intervention Phase
Hypovolemia
Organ Dysfunction
Other: restrictive and liberal fluid therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • incidence of intraoperative hypovolemia [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess) [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: restrictive fluid
Restrictive fluid administration: 6 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)
Other: restrictive and liberal fluid therapy
In both group, when hypovolemia is suspected (peak aortic velocity variation > 13%): fluid bolus (hydroxyethyl starch 130/0.4/6%) according to a predefined algorithm designed to maintain peak aortic velocity < 13% and no further increases in SV
Experimental: liberal fluid
Liberal fluid administration: 12 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)
Other: restrictive and liberal fluid therapy
In both group, when hypovolemia is suspected (peak aortic velocity variation > 13%): fluid bolus (hydroxyethyl starch 130/0.4/6%) according to a predefined algorithm designed to maintain peak aortic velocity < 13% and no further increases in SV

Detailed Description:

Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains unanswered. Although recent studies suggest that intraoperative fluid restriction may reduce postoperative morbidity and promote faster recovery, extrapolation to individual patients remains difficult. Indeed, whether fluid overload may expose tissue to oedema, impairing oxygenation and wound healing, fluid restriction may, conversely, expose to hypovolemia, which occurs frequently during abdominal surgery, leading to tissue hypoperfusion and organ dysfunction. To date, the restrictive and liberal fluid substitution strategies have not been compared using a goal-directed approach. In addition, recent data suggest that targeting early indicators of hypoperfusion, such as central venous oxygen saturation (ScvO2), which reflects the oxygen delivery/consumption relationship, may be important in the management of patients undergoing major surgery. No data are available on the effects of intraoperative fluid volume replacement strategy on ScvO2 modifications.

The purpose of this study is first to evaluate the influence of restrictive and liberal fluid replacement strategies on both hypovolemia and postoperative organ dysfunction using an oesophageal doppler goal-directed approach (with goal = peak aortic velocity variation and stroke volume optimization) during major abdominal surgery. The second objective is to investigate the effects of fluid loading on ScvO2 modifications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major intraabdominal surgery

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Body mass index > 35 kg/m2
  • Emergency surgery
  • Coagulopathy
  • Sepsis or Systemic inflammatory response syndrome (SIRS)
  • Hepatic failure (prothrombin ratio < 50%, factor V < 50%)
  • Contraindication for epidural analgesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852449

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel Futier University Hospital, Clermont-Ferrand
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00852449     History of Changes
Other Study ID Numbers: CHU-0045
Study First Received: February 26, 2009
Last Updated: October 4, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Intraoperative fluid
Monitoring
Oesophageal Doppler
Abdominal surgery
major abdominal surgery

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014