Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01295190
Other study ID # Fudickar3
Secondary ID
Status Completed
Phase N/A
First received February 11, 2011
Last updated May 21, 2014
Start date June 2009
Est. completion date August 2010

Study information

Verified date May 2014
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- Children scheduled for heart surgery including cardiopulmonary bypass

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Schleswig-Holstein Kiel Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic acidosis during cardiopulmonary bypass Changes of pH, base excess and lactate relative to baseline are analysed. 2 hours No
Secondary Outcome parameter Duration of intensive care treatment and time to dismission from hospital are compared between groups. 1 month No
See also
  Status Clinical Trial Phase
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Completed NCT03317444 - Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease Phase 3
Recruiting NCT05582824 - Lactate Metabolism in the Hypoperfused Critically Ill
Active, not recruiting NCT04010630 - Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in ICU N/A
Completed NCT02303548 - Bicarbonate in Patients With Out-of-hospital Cardiac Arrest Phase 2
Recruiting NCT01860001 - Incidence of Postoperative Ketosis and Metabolic Acidosis N/A
Completed NCT01452412 - Alkali Therapy in Chronic Kidney Disease Phase 2/Phase 3
Terminated NCT03710291 - Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis Phase 3
Completed NCT02476253 - Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill Phase 3
Completed NCT05940935 - The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
Withdrawn NCT03846258 - High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy Phase 4
Completed NCT05970094 - Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5 N/A
Recruiting NCT05784389 - Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5 N/A
Terminated NCT04727528 - Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease Phase 3
Completed NCT02098356 - Comparison of High Versus Low Bicarbonate Hemodialysis N/A
Recruiting NCT03897101 - Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Terminated NCT01894594 - Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease Phase 1
Completed NCT01075750 - Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants N/A
Completed NCT01293266 - Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation N/A
Completed NCT05147051 - Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients Phase 2