Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

This study is currently recruiting participants.

Verified by Haukeland University Hospital, November 2008

First Received: May 2, 2007 Last Updated: November 19, 2008 History of Changes

Sponsored by:	Haukeland University Hospital
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00468793

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 IV

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Postoperative morbidity [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

serum creatinine [ Time Frame: postoperative day 3 ] [ Designated as safety issue: Yes ]

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
2: Active Comparator 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
1: Experimental ScvO2 guided fluid therapy	Procedure: Intravenous fluid The same intravenous fluids will be used in both arms but the volume will be different

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468793

Contacts

Contact: Gro Østgaard, MD

4755976850

gro.ostgaard@helse-bergen.no

Locations

Norway
Haukeland University Hospital	Recruiting
Bergen, Norway, 5021
Contact: Gro Østgaard gro.ostgaard@helse-bergen.no
Principal Investigator: Ib Jammer

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Study Chair:

Gro Østgaard, M.D., PH.D.

Haukeland University Hospital

More Information

No publications provided

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

Keywords provided by Haukeland University Hospital:

central venous saturation
bowel surgery
morbidity
intravenous infusions

ClinicalTrials.gov processed this record on May 06, 2009