NCT01295190

Brief Summary

Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary bypass at our institution without complications. However, propofol may cause propofol infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS. Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary bypass, propofol has recently been substituted by sevoflurane during pediatric cardiopulmonary bypass at our institution. In this study the effect of substituting propofol by sevoflurane on metabolic acidosis and outcome are examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

February 11, 2011

Last Update Submit

May 21, 2014

Conditions

Metabolic Acidosis

Outcome Measures

Primary Outcomes (1)

  • Metabolic acidosis during cardiopulmonary bypass

    Changes of pH, base excess and lactate relative to baseline are analysed.

    2 hours

Secondary Outcomes (1)

  • Outcome parameter

    1 month

Study Arms (2)

Propofol

Patients receiving Propofol during cardiopulmonary bypass.

Sevoflurane

Patients receiving sevoflurane during cardiopulmonary bypass

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children scheduled for heart surgery including cardiopulmonary bypass.

You may qualify if:

  • Children scheduled for heart surgery including cardiopulmonary bypass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Axel Fudickar, Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

June 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

DE(1)