Renal dysfunction after CABG surgery
Conditions
Interventions
Product Name: CicloMulsion
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Other descriptive name: cyclosporine, cyclosporin A
Concentration unit: m
Sponsors
Skanes University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The study patient is scheduled for non-emergent (decision to operate more than one hour before start of surgery) CABG surgery. 2. Preoperative CyC eGFR or MDRD eGFR is 15-90. eGFR will be calculated using both creatinine (MDRD) and CyC . The lowest eGFR value will be used as inclusion criteria. 3. The patient has given his/her written consent to participate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: 1. The patient has an uncontrolled hypertension. 2. Hypersensitivity to the active drug or vehicle, including egg-, soya- or peanut protein;. 3. The patient is pregnant or is a fertile woman. 4. The patient has been treated with ciclosporin within 4 weeks prior to the surgery. 5. The patient has a known ongoing malignancy. 6. The patient has ongoing immunosuppressive treatment. 7. The patient has severe hepatic dysfunction. 8. The patient is treated with dialysis. 9. The patient has pre-operatively ongoing and/or increasing clinical infection with CRP levels of >50 mg/L. Clinical signs of infection may or may not be present. Increase in CRP due to signs of cardiac origin, according to the investigator, should not be considered as exclusion criteria. 10. The patient has a severe ongoing viral infection, including HIV, hepatitis C, current or history of hepatitis B. 11. For non-allowed and restricted ongoing and concomitant medications, see Protocol section 12.2. 12. The patient is planned for Off-pump CABG surgery. 13. The patient is included in other ongoing clinical trial. 14. For any other reason, the patient is unsuitable to participate in the study, according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of ciclosporin, with brand name CicloMulsion®, given preoperatively in CABG study patients to reduce the degree of AKI after CABG surgery. A number of biological markers for kidney function will be evaluated as mentioned in 4.4. ;Secondary Objective: Secondary objectives will be related to the study drugs potential effect on brain and heart. These will be evaluated by specific biomarkers as mentioned under 4.4. Also, safety parameters including incidence and nature of AE during the study period (Day 0 – 30) and safety biochemistry during Day 0 – 4 will be followed. ;Primary end point(s): Relative P-CyC change from day -1 to day 3;Timepoint(s) of evaluation of this end point: Changes in P-Cystatin C from the day before surgery to 3 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety aspects as AE and SAE will be followed during the whole study period. Safety biochemistry (plasma concentrations of K, Mg, urea, myoglobin, CK, bilirubin, ASAT, ALAT, GT, LD, CRP, exploratory immunologic biomarkers and leukocytes), body temperature and blood pressure will be followed Day -1 – 4. Leg wound infection scored according accepted scoring system (Appendix B);Timepoint(s) of evaluation of this end point: Each patient will be followed from the day before surgery until 30 days after. Endpoints will have different timepoints of evaluation. | — |
Countries
Sweden
Contacts
Public ContactDept of Cardiothoracic Surgery
Skanes University Hospital
Outcome results
None listed