NCT00468793

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 10, 2009

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

May 2, 2007

Last Update Submit

June 5, 2009

Conditions

Perioperative Care

Keywords

central venous saturationbowel surgerymorbidityintravenous infusions

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbidity

    postoperative day 30

Secondary Outcomes (1)

  • serum creatinine

    postoperative day 3

Study Arms (2)

2

ACTIVE COMPARATOR

Fluid therapy guided by blood pressure and urine production

Procedure: Intravenous fluid

1

EXPERIMENTAL

ScvO2 guided fluid therapy

Procedure: Intravenous fluid

Interventions

Intravenous fluidPROCEDURE

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective bowel surgery,
  • Able to give informed consent

You may not qualify if:

  • Coagulation defect,
  • Renal failure,
  • Valvular stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Study Officials

  • Gro Østgaard, M.D., PH.D.

    Haukeland University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 10, 2009

Record last verified: 2009-05

Locations

NO(1)