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Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468793
First Posted: May 3, 2007
Last Update Posted: June 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Haukeland University Hospital
  Purpose
Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided by central venous oxygen saturation. The primary outcome will be complications after surgery.

Condition Intervention Phase
Perioperative Care Procedure: Intravenous fluid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Postoperative morbidity [ Time Frame: postoperative day 30 ]

Secondary Outcome Measures:
  • serum creatinine [ Time Frame: postoperative day 3 ]

Estimated Enrollment: 240
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Fluid therapy guided by blood pressure and urine production
Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different
Experimental: 1
ScvO2 guided fluid therapy
Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective bowel surgery,
  • Able to give informed consent

Exclusion Criteria:

  • Coagulation defect,
  • Renal failure,
  • Valvular stenosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468793


Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Chair: Gro Østgaard, M.D., PH.D. Haukeland University Hospital
  More Information

Responsible Party: Gro Østgaard, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00468793     History of Changes
Other Study ID Numbers: 16312
First Submitted: May 2, 2007
First Posted: May 3, 2007
Last Update Posted: June 10, 2009
Last Verified: May 2009

Keywords provided by Haukeland University Hospital:
central venous saturation
bowel surgery
morbidity
intravenous infusions