CAPHI. Profylactic effect of Ca2+ sensitizer versus phosphodiesterase inhibitor infusion at CAGB patients with preoperative low ejection fraction. A prospective randomised clinical trial. - CAPHI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002653-31-DK

Enrollment

Registered

2004-09-30

Start date

2004-11-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Simdax Product Name: simdax Product Code: 970223 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Levosimendan CAS Number: 141505-33-1 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: s- creatinin> 150mM albumin 1,5 systolic bloodpressure 100/s other kind of heart surgery in same operation preoperative intraaortic balloon pump preoperativ need of inotropi pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Cardiac index, ECG, Mean artery pressure, mean pulmonar artery pressure, central venous pressure, arterial and venous saturation, systemic and pulmonar vascular resistance, pulmonar capillar wedge pressure, need of inotropica - epinephrine, norepinephrine and intraaortic balloon pump. Operation time, time at cardiopulmonal bypass, pressens of rhytme disturbances, need of pacing, Creatin kinaseMB, troponin T, need of fluid, S- creatinin, Alanin amiotransferase, INR, albumin. Sideeffects And other standard parameters to evaluate the clinical condition. ;Secondary Objective: Days in hospital after the operation, morbiditet, mortatiltet;Primary end point(s): Goals for the patient: CI>2,2 MAP> mmHg hemoglobin>5,5 mmol/L diurese >0,6 ml/kg/hour Terapeutic intervension: - CI> 2,2 l/min/m2 and MAP> 65mmHg -> norepinephrine 0,05-0,1µg/ kg/ min - CI 15 and PWCP> 18 -> 1) epinephrine 0,05-0,02µg/ kg/ min 2) double the speed of the trial medicin infusion 3) give the patient intraaortic balloon pump 4) break the code and give the patient the trial medicin he wasn´t randomised for. b) CVP 500ml voluven ( 6%) - Heart frekvens > 70 -> AAI or DDD pace	—

Measure

Time frame

Main Objective: Cardiac index, ECG, Mean artery pressure, mean pulmonar artery pressure, central venous pressure, arterial and venous saturation, systemic and pulmonar vascular resistance, pulmonar capillar wedge pressure, need of inotropica - epinephrine, norepinephrine and intraaortic balloon pump. Operation time, time at cardiopulmonal bypass, pressens of rhytme disturbances, need of pacing, Creatin kinaseMB, troponin T, need of fluid, S- creatinin, Alanin amiotransferase, INR, albumin. Sideeffects And other standard parameters to evaluate the clinical condition. ;Secondary Objective: Days in hospital after the operation, morbiditet, mortatiltet;Primary end point(s): Goals for the patient: CI>2,2 MAP> mmHg hemoglobin>5,5 mmol/L diurese >0,6 ml/kg/hour Terapeutic intervension: - CI> 2,2 l/min/m2 and MAP> 65mmHg -> norepinephrine 0,05-0,1µg/ kg/ min - CI 15 and PWCP> 18 -> 1) epinephrine 0,05-0,02µg/ kg/ min 2) double the speed of the trial medicin infusion 3) give the patient intraaortic balloon pump 4) break the code and give the patient the trial medicin he wasn´t randomised for. b) CVP 500ml voluven ( 6%) - Heart frekvens > 70 -> AAI or DDD pace

—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026