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Intraoperative Hypovolemia and Fluid Therapy

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00852449
Enrollment
70
Registered
2009-02-27
Start date
2008-05-31
Completion date
2009-01-31
Last updated
2012-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia, Organ Dysfunction

Keywords

Intraoperative fluid, Monitoring, Oesophageal Doppler, Abdominal surgery, major abdominal surgery

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.

Interventions

OTHERrestrictive 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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incidence of intraoperative hypovolemiaintraoperative

Secondary

MeasureTime frame
postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess)postoperative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026