CAPHI. Profylactic effect of Ca2+ sensitizer versus phosphodiesterase inhibitor infusion at CAGB patients with preoperative low ejection fraction. A prospective randomised clinical trial. - CAPHI
Phase 1
- Conditions
- Perioperative use of Milrinon to CAGB patients has shown to reduce postoperative complications. Levosimendan improves cardiac performance without interfering with the calcium turnover and there by use of cellular energi. This study wants to document a better cardiac performance in CABG patients with preoperative low ejection fraction EF after prophylactic calcium sensitizer- versus phosphodiesterase-infusion in a double-blinded randomised clinical trial.
- Registration Number
- EUCTR2004-002653-31-DK
- Lead Sponsor
- Odense University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
elective CABG patient with a preoperative ejection fraction below 35%
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
s- creatinin> 150mM
albumin< 35g/l
INR > 1,5
systolic bloodpressure <90mmHg
trombocyt<100x10^9
known coagulopati
p- kalium<3 mmol/l
heart frekvens >100/s
other kind of heart surgery in same operation
preoperative intraaortic balloon pump
preoperativ need of inotropi
pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method