Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass (PRISKIKO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01295190
First received: February 11, 2011
Last updated: May 21, 2014
Last verified: May 2014

February 11, 2011
May 21, 2014
June 2009
August 2010   (final data collection date for primary outcome measure)
Metabolic acidosis during cardiopulmonary bypass [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Changes of pH, base excess and lactate relative to baseline are analysed.
Same as current
Complete list of historical versions of study NCT01295190 on ClinicalTrials.gov Archive Site
Outcome parameter [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Duration of intensive care treatment and time to dismission from hospital are compared between groups.
Same as current
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Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

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.

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

Observational
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Non-Probability Sample

Children scheduled for heart surgery including cardiopulmonary bypass.

Metabolic Acidosis
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  • Propofol
    Patients receiving Propofol during cardiopulmonary bypass.
  • Sevoflurane
    Patients receiving sevoflurane during cardiopulmonary bypass
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children scheduled for heart surgery including cardiopulmonary bypass
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01295190
Fudickar3
No
Axel Fudickar, University of Schleswig-Holstein
University of Schleswig-Holstein
Not Provided
Principal Investigator: Axel Fudickar, Dr. University of Schleswig-Holstein
University of Schleswig-Holstein
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP