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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00852449
Other study ID # CHU-0045
Secondary ID
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


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
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