N . Kachoueian et al .: J Extra Corpor Technol 2024 , 56 , 159 – 166 161
Company , Mashhad , Iran ) or lactated Ringer ’ s solution-based ( modified ) del Nido solutions were administered in ratio of 1:4 autologous blood : crystalloid . Compositions were according to the protocol in our setting presented in Table 1 .
Solutions were administered with the same protocol and the dose of 20 mL / kg of the body weight ( maximum 1000 mL per patient weighing over 50 kg ). The delivery temperature of the solution was 4 ° C and the system pressure was 100 – 200 mmHg and the administration flow was 200 – 300 mL / min .
Data collection and outcomes
Demographic data including age , sex , body surface area ( BSA ), and body mass index ( BMI ), blood pressure , heart rate , blood urea nitrogen ( BUN ), creatinine , amount of blood product usage , urination and hemofiltration volume on CPB were measured during the study period and recorded into the trial checklist . Primary outcomes were EF ( before sternotomy and after weaning from CPB in the operation room ), duration of mechanical ventilation , post-surgical arrhythmia incidence , and inotrope administration after surgery . Secondary outcomes were serum level of cardiac troponin ( cTnI ) and lactate dehydrogenase at the preoperative , after cross-clamp removal , ICU admission , and 24 h after ICU admission . All patient ’ s background information and clinical outcomes along with vital sign monitoring reports were recorded in the trial checklist .
Statistical analysis
Study data were entered into the Statistical Package for the Social Sciences ( SPSS ) ( IBM Inc ., NY , USA ) Ver . 22.0 software for data analysis . The normality of study data was analyzed and mean ± standard deviation and frequency percentages were used to describe quantitative and qualitative variables in normal and median ± interquartile range ( IQR ) for nonparametric variables . Independent sample t-test statistical test was applied for comparing means between two groups . Mann – Whitney U test was applied for comparing quantitative data with non-parametric distribution . The Chi-square test was used for comparing frequencies between groups . p-values less than 0.05 was considered significant . The power of analysis was set at 80 %.
According to the findings of Kantathut et al ., the mean ( SD ) for ICU stay was 2 ( 1.5 ) days for the modified del Nido group [ 12 ]. Considering a one-day difference between the study groups , a = 0.05 , statistical power = 0.9 and using the Mann – Whitney test for power analysis , the sample size was determined as equally 51 in each group . GPower 3.1 was applied for the calculation .
Results
The study flow using the Consolidated Standards of Reporting Trials ( CONSORT ) flow diagram is presented in Figure 1 . Finally , from 120 patients screened for the recruitment , 109 patients were recruited . The mean age and body mass index among study participants were 61.41 ± 8.41 years and 27.04 ± 3.84 kg / m 2 respectively . 80 % of the patients were males . Included patients were randomly allocated to LR DN ( n = 57 ) andPLDN ( n = 52 ) groups . Mean of age and BMI were not significantly different between the two groups . No mortality was observed and arrhythmias occurred in nine patients , four in the LR DN and five in the PL DN ( p : 0.56 ). Markers of renal function were similar among patients of both groups in all of the measurements . The incidence of arrhythmia was similar between the two groups ( Table 2 ).
The mean of age , BMI , BSA , and male-to-female ratio were similar in patients of the two groups . Meantime to arrest in patients of the LR DN group was significantly lower than patients of the PL DN group ( 47.50 ± 16.60 vs . 54.59 ± 18.46 s ; p = 0.04 ). The mean of the return time to sinus rhythm among patients of the LR DN group was similar to that of patients of the PL DN group ( 5.30 ± 6.23 vs . 6.01 ± 5.99 min ; p = 0.55 ). ICU stay , CPB , aortic cross clamping , frequency of arrhythmia and ejection fraction of patients at pre- and post-operative measurements were similar ( Table 2 ).
At the postoperative period , the serum level of cardiac enzymes was not significantly different among patients of both groups . At the ICU entrance time , only the serum level of cTnI among patients of LR DN groups was significantly higher than patients of PL DN group ( p = 0.005 ). 24 h after ICU entrance , serum level of creatine phosphokinase-MB ( CPK-MB ) and cTnI were significantly higher among patients of LR DN group compared with the patients of the PL DN group . Details of comparisons of laboratory tests among patients of LR DN and PL DN groups at different measurement times were presented in the Figure 2 and Table 3 .
Frequency of blood products transfused were similar between patients of both groups in operation room and ICU ( Table 4 ).
Values of arterial blood gases was similar between patients of both groups preoperatively , in the operation room and in the ICU ( Table 5 ).
There was significantly higher epinephrine administration rates in the operation room in the LR DN compared with the PL DN group ( 29.8 % vs . 11.5 %; p : 0.019 ). Significant difference in use of other inotropes between two groups was not observed ( Table 6 ).
There was only one redosing in the modified DN group which was not significantly different from control group ( p = 0.337 ). The redosing volume was also half the first dose .
Discussion
The present study aimed to compare the clinical impact of a modified del Nido ( DN ) cardioplegia solution based on lactated Ringer ’ s solution with the standard Plasma-Lyte based DN cardioplegia solution on myocardial function , biochemical parameters , and clinical outcomes in patients undergoing CABG with CPB . Although no significant differences in ejection fraction and duration of ICU stay were observed between the two groups , there were notable differences in biochemical parameters at the postoperative time point . Specifically , the modified DN group exhibited higher levels of CPK-MB , and cTnI compared to the conventional DN cardioplegia group . The elevated cTnI levels in the modified DN group persisted for up to 24 h after ICU admission . Blood gas analysis and transfusion