Warm blood cardioplegia with Normacor® in complex cardiac surgery in adults: a randomized trial
Purpose of the study
Comparison of two asystole maintenance regimens using Normacor. Group 1 included intermittent administration of Solution No. 2; Group 2 included no Solution No. 2, with repeated administration in the event of resumption of ventricular activity.
The mean duration of aortic cross-clamping was similar in both groups
The average duration of aortic clamping in Group 1 was 88.2 minutes, in Group 2 - 96.4 minutes.
Resumption of ventricular activity was observed more frequently in patients in Group 2
At the intraoperative stage, the resumption of ventricular activity occurred in 12.5% of cases in Group 1 compared to 50% in Group 2, with the difference being statistically significant (p=0.0275).
Resumption of ventricular activity
Group 1
Group 2
Average number of repeated administrations and volume of cardioplegia
The average number of repeat Normacor cardioplegia administrations in Group 1 was four, while in Group 2 it was a single administration. The average cardioplegia volume per procedure was 760 ml in Group 1 and 457 ml in Group 2.
The type of cardiac arrest was similar across groups
Asystole was the mechanism of intraoperative cardiac arrest in 100% (18/18) and 94% (17/18) of cases in Groups 1 and 2, respectively.
Group 1
Group 2
The need for inotropes was comparable between groups
At the intraoperative stage, the need for inotropic agents differed slightly: in Group 1 - 20% of cases, in Group 2 - 29% of cases.
Need for inotropes
Group 1
Group 2
In both groups, metabolism was physiological
Arterial blood pH levels of patients in Group 1 and Group 2. Dotted lines indicate the normal range.
Venous blood pH levels of patients in Group 1 and Group 2. Dotted lines indicate the normal range.
Blood hematocrit levels of patients in Group 1 and Group 2. Dotted lines indicate the normal range.
Conclusion
The overall clinical trial data demonstrate comparable efficacy and safety of both methods of Normacor cardioplegic solution administration described in the instructions.
