Crystalloid hypothermic and blood normothermic cardioplegia
This clinical trial was conducted as part of the registration of Normacor®.
The crystalloid solution Custodiol and the innovative blood normothermic solution Normacor® were compared.
The study included 90 patients randomized 1:1 to cardioplegia with Normacor or Custodiol. Of the 90 patients, 85 completed the study per protocol: 40 in the Normacor group and 45 in the Custodiol group.
A difference between the Normacor® and Custodiol groups was demonstrated for efficacy criteria
Cardiac arrest through asystole (rather than fibrillation) was observed more often in the Normacor® group
Spontaneous rhythm restoration without defibrillation was more frequent in the Normacor® group
Defibrillation occurred significantly less often in the Normacor® group than in the Custodiol group. Spontaneous restoration of cardiac activity occurred in 97.5% of cases in the Normacor® group versus 53.3% in the Custodiol group (*P<0.001; P<0.0001).
Cardiotonic support before transfer to the ICU was required less often in the Normacor® group
Cardiotonic therapy was used in 47.5% of cases in the Normacor® group and in 71.1% of cases in the Custodiol group. At the intraoperative stage, cardiotonic support was required statistically significantly less often (*P<0.05; P=0.0452).
Metabolism was more physiological when Normacor cardioplegic solution was used
Arterial blood pH levels. The solid line shows the group mean; the light band shows the normal range.
BE values in arterial and venous blood. The solid line shows the group mean; the light band shows the normal BE range from -2 to +2.
Statistically significant differences in arterial blood pH between the Normacor® and Custodiol groups were found during the main stage of surgery (mean value 7.436 in the Normacor® group versus 7.327 in the Custodiol group; P<0.001; P<0.0001) and immediately after surgery (mean value 7.412 in the Normacor® group versus 7.442 in the Custodiol group; P<0.01; P=0.0056).
Statistically significant differences in arterial blood BE between the Normacor® and Custodiol groups were found during the main stage of surgery (mean value 1.020 mmol/L in the Normacor® group versus -3.724 mmol/L in the Custodiol group; P<0.001; P<0.0001).
In venous blood, the mean value was 1.685 mmol/L in the Normacor® group versus -2.160 mmol/L in the Custodiol group (P<0.001; P<0.0001).
Mean duration of mechanical ventilation was lower when Normacor solution was used
Conclusion
The overall clinical trial data indicate better cardiac protection with Normacor compared with Custodiol.
Overall, Normacor demonstrated good safety and tolerability comparable with the Custodiol group.
Normacor should be used not only in standard situations but also in patients at high risk of intraoperative cardiovascular complications and in patients with severe concomitant pathology.
