Traditional Versus ScvO2 Guided Perioperative Fluid Therapy | NCT00468793

Studies
Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

NCT00468793

Sponsor

Haukeland University Hospital

Status

Completed

Last Update Posted

Jun 10, 2009Estimated

Enrollment

240Estimated

Phase

Phase 4

Conditions

Perioperative Care

Interventions

Intravenous fluid

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

May 2, 2007

First Submission Date that Met QC Criteria

May 2, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2009

Last Update Posted Date

Jun 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intravenous fluid	Procedure	The same intravenous fluids will be used in both arms but the volume will be different	1 2

Measure	Description	Time Frame
Postoperative morbidity		postoperative day 30

Measure	Description	Time Frame
serum creatinine		postoperative day 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective bowel surgery,
Able to give informed consent

Exclusion Criteria:

Coagulation defect,
Renal failure,
Valvular stenosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gro Østgaard, M.D., PH.D.	Haukeland University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5021	Norway