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Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

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ClinicalTrials.gov Identifier: NCT00468793
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Haukeland University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Perioperative Care Procedure: Intravenous fluid Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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



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

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


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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

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

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

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