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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
May 2, 2007
May 3, 2007
June 10, 2009
April 2007
May 2009   (Final data collection date for primary outcome measure)
Postoperative morbidity [ Time Frame: postoperative day 30 ]
Postoperative morbidity
Complete list of historical versions of study NCT00468793 on ClinicalTrials.gov Archive Site
serum creatinine [ Time Frame: postoperative day 3 ]
Not Provided
Not Provided
Not Provided
 
Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Perioperative Care
Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different
  • Active Comparator: 2
    Fluid therapy guided by blood pressure and urine production
    Intervention: Procedure: Intravenous fluid
  • Experimental: 1
    ScvO2 guided fluid therapy
    Intervention: Procedure: Intravenous fluid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective bowel surgery,
  • Able to give informed consent

Exclusion Criteria:

  • Coagulation defect,
  • Renal failure,
  • Valvular stenosis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00468793
16312
No
Not Provided
Not Provided
Gro Østgaard, Haukeland University Hospital
Haukeland University Hospital
Not Provided
Study Chair: Gro Østgaard, M.D., PH.D. Haukeland University Hospital
Haukeland University Hospital
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP