Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

Perioperative Care Clinical Trial

Official title:

Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468793
• Other study ID #: 16312
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: June 5, 2009
• Start date: April 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective bowel surgery,

• Able to give informed consent

Exclusion Criteria:

• Coagulation defect,

• Renal failure,

• Valvular stenosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perioperative Care

Intervention

Procedure:
• Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity		postoperative day 30	Yes
Secondary	serum creatinine		postoperative day 3	Yes