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Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00468793
First received: May 2, 2007
Last updated: June 5, 2009
Last verified: May 2009
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Gro Østgaard, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00468793     History of Changes
Other Study ID Numbers: 16312
Study First Received: May 2, 2007
Last Updated: June 5, 2009
Health Authority: Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on November 27, 2014