Intraoperative Hypovolemia and Fluid Therapy

Hypovolemia Clinical Trial

Official title:

Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852449
• Other study ID #: CHU-0045
• Status: Terminated
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: October 4, 2012
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypovolemia
• Organ Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of intraoperative hypovolemia		intraoperative	Yes
Secondary	postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess)		postoperative	Yes