Acute kidney injury postoperatively in connection with surgery for congenital heart disease
Conditions
Interventions
Trade Name: Simdax
Product Name: Simdax
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Trade Name: Milrinone
Product
Sponsors
Sahlgrenska University Hospital / The Queen Silvia Children´s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and male children between 1 and 12 months of age 3. Non-restrictive VSD (corrective surgery) 4. Complete AVSD (biventricular repair) 5. Tetralogy of Fallot Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unbalanced AVSD 2. Age less than one month and more than one year 3. acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery 4. Pre-existing renal disease 5. Liver impairment or disease 6. Infection 7. Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day 8. Allergy to Levosimendan or previous use of it, 9. Severe arrhythmias needing pace-maker treatment prior to the operation 10. Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation 11. Severe uncorrected hypotension where the initiation of anesthesia is postponed for its correction 12. Re-operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess the efficacy of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs) having creatinine as an endpoint marker.;Secondary Objective: The secondary objectives are to study the hemodynamic parameters, fluid balance, the level of inflammation and other plasma kidney biomarkers (like cystatin C and NGAL), and markers of neural injury. Other parameters to stuidy will be length of surgery, length of CPB, length of mechanical ventilation postoperatively, length of vasoactive therapy, number of vasoactive medications and total amount of infused vasoactive drugs. ;Primary end point(s): AKI is usually defined as 50% increase in creatinine within 48 hours. Accordingly, the primary outcome in this study is the creatinine level on the second postoperative day. ;Timepoint(s) of evaluation of this end point: On the second postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the hemodynamic parameters, fluid balance, the level of inflammation and other plasma kidney biomarkers (like cystatin C and NGAL), and markers of neural injury. Other parameters will also be assessed such as length of surgery, length of CPB, length of mechanical ventilation postoperatively, length of vasoactive therapy, number of vasoactive medications and total amount of infused vasoactive drugs. ;Timepoint(s) of evaluation of this end point: After the termination of the study the blood samples will be analyzed . The capacity of the analyzing laboratory will determine the time point in which this end point will be evaluated. | — |
Countries
Finland, Sweden
Contacts
Public ContactAnOpIVA
Sahlgrenska University Hospital / The Queen Silvia Children´s Hospital
Outcome results
None listed