Intraoperative Hypovolemia and Fluid Therapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypovolemia; Organ Dysfunction
• Intervention / Treatment: Other: restrictive and liberal fluid therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: restrictive fluid; Restrictive fluid administration: 6 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)	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
Experimental: liberal fluid; Liberal fluid administration: 12 ml kg-1 h-1 of crystalloids (lactated Ringer's solution)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of intraoperative hypovolemia	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess)	postoperative

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Monitoring; major abdominal surgery; Abdominal surgery; Intraoperative fluid; Oesophageal Doppler
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: CHU-0045