CompletedNCT00468793Updated Jun 10, 2009

Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

A Phase 4 interventional study of Intravenous fluid in Perioperative Care, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-10.

Sponsored by Haukeland University Hospital · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Perioperative Care

Keywords

central venous saturation
bowel surgery
morbidity
intravenous infusions

In context

Lead sponsor

Haukeland University Hospital is the lead sponsor of 283 studies on the registry; 59 are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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Inclusion criteria

Elective bowel surgery,
Able to give informed consent

Exclusion criteria

Exclusion Criteria:

Coagulation defect,
Renal failure,
Valvular stenosis

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 240 participants (estimated)

Study arms

Active comparator
2
Fluid therapy guided by blood pressure and urine production
Procedure: Intravenous fluid
Experimental
1
ScvO2 guided fluid therapy
Procedure: Intravenous fluid

Interventions

ProcedureIntravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different

What researchers measure

Primary outcomes

Postoperative morbidity
Time frame: postoperative day 30

Secondary outcomes

serum creatinine
Time frame: postoperative day 3

Study locations

1 site

Haukeland University Hospital
Bergen, 5021, Norway

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00468793
Lead sponsor: Haukeland University Hospital
First posted: May 3, 2007
Start date: Apr 2007
Primary completion: May 2009
Completion: May 2009
Last update: Jun 10, 2009

Study contacts

Gro Østgaard, M.D., PH.D.

study chair · Haukeland University Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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