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
  Purpose

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.


Condition
Metabolic Acidosis

Study Type: Observational
Official Title: Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 200
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Propofol
Patients receiving Propofol during cardiopulmonary bypass.
Sevoflurane
Patients receiving sevoflurane during cardiopulmonary bypass

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

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children scheduled for heart surgery including cardiopulmonary bypass.

Criteria

Inclusion Criteria:

  • Children scheduled for heart surgery including cardiopulmonary bypass
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01295190

Locations
Germany
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Axel Fudickar, Dr. University of Schleswig-Holstein
  More Information

No publications provided

Responsible Party: Axel Fudickar, MD, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01295190     History of Changes
Other Study ID Numbers: Fudickar3
Study First Received: February 11, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Propofol
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014