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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

February 26, 2009
October 4, 2012
May 2008
January 2009   (final data collection date for primary outcome measure)
incidence of intraoperative hypovolemia [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00852449 on ClinicalTrials.gov Archive Site
postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess) [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intraoperative Hypovolemia and Fluid Therapy
Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Hypovolemia
  • Organ Dysfunction
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: restrictive fluid
    Restrictive fluid administration: 6 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)
    Intervention: Other: restrictive and liberal fluid therapy
  • Experimental: liberal fluid
    Liberal fluid administration: 12 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)
    Intervention: Other: restrictive and liberal fluid therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00852449
CHU-0045
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Emmanuel Futier University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP