Intraoperative Hypovolemia and Fluid Therapy

Phase 4

Terminated

• Conditions: Hypovolemia; Organ Dysfunction
• Interventions: Other: restrictive and liberal fluid therapy

• Registration Number: NCT00852449
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
restrictive fluid	restrictive and liberal fluid therapy	Restrictive fluid administration: 6 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)
liberal fluid	restrictive and liberal fluid therapy	Liberal fluid administration: 12 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)

Primary Outcome Measures

Name	Time	Method
incidence of intraoperative hypovolemia	intraoperative

Secondary Outcome Measures

Name	Time	Method
postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess)	postoperative