Ciclosporin to Protect Renal function In Cardiac Surgery. CiPRICS. A Phase II Double Blind Randomized Placebo Controlled Study. - CiPRICS

Skanes University Hospital0 个研究点开始时间: 2014年12月22日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Skanes University Hospital