Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass (PRISKIKO)
Primary Purpose
Metabolic Acidosis
Status
Completed
Phase
Locations
Germany
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Metabolic Acidosis
Eligibility Criteria
Inclusion Criteria:
- Children scheduled for heart surgery including cardiopulmonary bypass
Sites / Locations
- University Hospital Schleswig-Holstein
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Propofol
Sevoflurane
Arm Description
Patients receiving Propofol during cardiopulmonary bypass.
Patients receiving sevoflurane during cardiopulmonary bypass
Outcomes
Primary Outcome Measures
Metabolic acidosis during cardiopulmonary bypass
Changes of pH, base excess and lactate relative to baseline are analysed.
Secondary Outcome Measures
Outcome parameter
Duration of intensive care treatment and time to dismission from hospital are compared between groups.
Full Information
NCT ID
NCT01295190
First Posted
February 11, 2011
Last Updated
May 21, 2014
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT01295190
Brief Title
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass
Acronym
PRISKIKO
Official Title
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome
Study Type
Observational
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In this retrospective and partially prospective observational study the charts of 200 children anesthetised for pediatric heart surgery are analysed since September 2007. 100 children received propofol and up to now 80 children received sevoflurane during cardiopulmonary bypass. Blood gas analysis, laboratory results and vital parameters are compared before and after cardiopulmonary bypass for each group. Duration of intensive care treatment and time to dismission from hospital are compared between groups. Changes relative to baseline are analysed by paired t-Test with correction for multiple testing. Differences between groups are analysed by unpaired t-Test with correction for multiple testing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis
7. Study Design
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Description
Patients receiving Propofol during cardiopulmonary bypass.
Arm Title
Sevoflurane
Arm Description
Patients receiving sevoflurane during cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Metabolic acidosis during cardiopulmonary bypass
Description
Changes of pH, base excess and lactate relative to baseline are analysed.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Outcome parameter
Description
Duration of intensive care treatment and time to dismission from hospital are compared between groups.
Time Frame
1 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children scheduled for heart surgery including cardiopulmonary bypass
Study Population Description
Children scheduled for heart surgery including cardiopulmonary bypass.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Fudickar, Dr.
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass
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