Intraoperative Hypovolemia and Fluid Therapy

NCT00852449 | Terminated Phase 4

• 1 other identifier: CHU-0045
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypovolemia; Organ Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• incidence of intraoperative hypovolemia

  intraoperative

Secondary Outcomes (1)

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

  postoperative

Study Arms (2)

restrictive fluid

EXPERIMENTAL

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

Other: restrictive and liberal fluid therapy

liberal fluid

EXPERIMENTAL

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

Other: restrictive and liberal fluid therapy

Interventions

restrictive and liberal fluid therapy 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; restrictive fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major intraabdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Related Publications (2)

• 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.

  PMID: 21173294 DERIVED

• 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.

  PMID: 21034476 DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Futier

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 5, 2012

Record last verified: 2012-10