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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

May 2, 2007
June 5, 2009
April 2007
May 2009   (final data collection date for primary outcome measure)
Postoperative morbidity [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
Postoperative morbidity
Complete list of historical versions of study NCT00468793 on ClinicalTrials.gov Archive Site
serum creatinine [ Time Frame: postoperative day 3 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00468793
16312
No
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