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Sponsored by: |
Haukeland University Hospital |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00468793 |
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 |
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Perioperative Care |
Procedure: Intravenous fluid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy |
Estimated Enrollment: | 240 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Fluid therapy guided by blood pressure and urine production
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Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different
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1: Experimental
ScvO2 guided fluid therapy
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Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gro Østgaard, MD | 4755976850 | gro.ostgaard@helse-bergen.no |
Norway | |
Haukeland University Hospital | Recruiting |
Bergen, Norway, 5021 | |
Contact: Gro Østgaard gro.ostgaard@helse-bergen.no | |
Principal Investigator: Ib Jammer |
Study Chair: | Gro Østgaard, M.D., PH.D. | Haukeland University Hospital |
Responsible Party: | Haukeland University Hospital ( Gro Østgaard ) |
Study ID Numbers: | 16312 |
Study First Received: | May 2, 2007 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00468793 History of Changes |
Health Authority: | Norway: Directorate for Health and Social Affairs |
central venous saturation bowel surgery morbidity intravenous infusions |