Intraoperative Hypovolemia and Fluid Therapy

NCT ID: NCT00852449

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-01-31

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.

Conditions

Hypovolemia; Organ Dysfunction

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Blinding Strategy: TRIPLE

Study Groups

restrictive fluid

Restrictive fluid administration: 6 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)

Group Type: EXPERIMENTAL

restrictive and liberal fluid therapy

Intervention Type: OTHER

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

liberal fluid

Liberal fluid administration: 12 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)

Group Type: EXPERIMENTAL

restrictive and liberal fluid therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Futier

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

References

Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.

Reference Type: DERIVED

PMID: 21173294 (View on PubMed)

Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.

Reference Type: DERIVED

PMID: 21034476 (View on PubMed)

Other Identifiers

CHU-0045

Identifier Type: -

Identifier Source: org_study_id