Clinical trial

A retrospective observational study of clinical outcomes of single-dose warm blood cardioplegia in cardiac surgery patients

Normacor has been proven to be safe and has no adverse reactions
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Clinical center
First Moscow State Medical University named after I.M. Sechenov, Ministry of Health of Russia (Moscow)
Study design
Observational, post-authorization safety study (PASS)
Observation group
150 patients
Primary endpoints
Development of intraoperative acute heart failure
Secondary endpoints
Postoperative catecholamine requirements, frequency of repeated cardioplegia administrations

Purpose of the study

To evaluate the safety and efficacy of the normothermic cardioplegic solution Normacor® and obtain additional information on dosing regimens during normothermic or moderately hypothermic cardiac surgery.

The results of the study showed

1

A single Normacor® cardioplegia perfusion provides myocardial protection for an average of 59 minutes

The maximum aortic clamping time per dose was 154 minutes.

154min
Maximum duration of aortic clamping
59min
Average duration of aortic cross-clamping
17min
Minimum duration of aortic cross-clamping
2

When using Normacor®, the heart effectively stopped and restored rhythm on its own

After removal of the aortic clamp, spontaneous rhythm restoration was recorded in 136 patients (90.07%). Cardiac arrest in the form of asystole was recorded in 150 patients (100%).

Spontaneous restoration of rhythm

90,07%
yes 90,07%no 9.93%

Cardiac arrest in the form of asystole

100%
asystole 100%no 0.00%
3

Blood composition changed during and after the operation without significant shifts

pH of arterial and venous blood
7.17.277.457.637.8pH
Before surgery
30 min CPB
End of operation
Admission to ICU
Arterial bloodVenous bloodnormal

Blood pH levels of patients. Each point represents one patient; the solid line is the median; the band is the normal range.

Potassium ion concentrations in arterial and venous blood
0246810K+, mmol/L
Before surgery
30 min CPB
End of operation
Admission to ICU
Arterial bloodVenous bloodnormal

Potassium ion concentrations in arterial and venous blood of the patients. Solid lines represent median values; the band represents the normal range of the parameter.

4

When the duration of aortic cross-clamping was up to 90 minutes, catecholamine support was rarely used

Of the 16 cases with aortic clamping duration greater than 90 minutes, adrenaline was used in 3 (18.8%) patients at a dose greater than 0.05 mcg/kg/min. Of the 134 cases of aortic clamping duration less than 90 minutes, catecholamine support was used in 4 (3%) patients, p=0.027.

Aortic clamp > 90 min · adrenaline was used

18,8%
yes 18,8%no 81.20%

Aortic clamp < 90 min · catecholamine support

3%
yes 3%no 97.00%
5

One administration of Normacor® was sufficient in most cases

Repeated administration of the solution was required only in isolated cases.

Is one dose of cardioplegia sufficient?
94,65%
  • 142One dose - 142 patients
  • 8Repeated dose - 8 cases

Conclusion

Normothermic solution Normacor® for blood cardioplegia can be used both for standard cardiac surgical interventions and for patients with a high risk of intraoperative complications associated with severe cardiovascular insufficiency or severe concomitant diseases.

The first dose of the solution provides myocardial protection for an average of 59 minutes. The longest surgery performed using one dose of Normacor® lasted 154 minutes.

Catecholamine support was rarely used for aortic cross-clamping durations of less than 90 minutes. Normacor® cardioplegic solution provides support for physiological myocardial metabolism and adequate myocardial protection during the intraoperative period.

JSC "CARDIOSYSTEMPHARMA"
Owner LP-No.(015032)-(RG-RU)
2a-1, Rabochaya, St. Khimki, Moscow Region, 141401 Russia
OUR SOCIAL MEDIA
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