Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

NCT ID: NCT00468793

Last Updated: 2009-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2

Fluid therapy guided by blood pressure and urine production

Group Type ACTIVE_COMPARATOR

Intravenous fluid

Intervention Type PROCEDURE

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

1

ScvO2 guided fluid therapy

Group Type EXPERIMENTAL

Intravenous fluid

Intervention Type PROCEDURE

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

Interventions

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Intravenous fluid

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective bowel surgery,
* Able to give informed consent

Exclusion Criteria

* Coagulation defect,
* Renal failure,
* Valvular stenosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haukeland University Hospital

Principal Investigators

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Gro Østgaard, M.D., PH.D.

Role: STUDY_CHAIR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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16312

Identifier Type: -

Identifier Source: org_study_id

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