Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial
Abstract Background Blood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whet...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | European Journal of Medical Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40001-023-01372-4 |
| _version_ | 1797577246135812096 |
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| author | Ahmed F. Elmahrouk Mohammad S. Shihata Osman O. AL-Radi Amr A. Arafat Musleh Altowaity Bayan A. Alshaikh Mohamed N. Galal Abdulbadee A. Bogis Haneen Y. Al Omar Wesal J. Assiri Ahmed A. Jamjoom |
| author_facet | Ahmed F. Elmahrouk Mohammad S. Shihata Osman O. AL-Radi Amr A. Arafat Musleh Altowaity Bayan A. Alshaikh Mohamed N. Galal Abdulbadee A. Bogis Haneen Y. Al Omar Wesal J. Assiri Ahmed A. Jamjoom |
| author_sort | Ahmed F. Elmahrouk |
| collection | DOAJ |
| description | Abstract Background Blood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery. Methods The study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%. Results Between January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2–Q3: 10–19) days in the CC group vs. 13 (10–21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6–7.45) vs. 5 (2.6–7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2–Q3: 18.73–41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55). Conclusions Custodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017 |
| first_indexed | 2024-03-10T22:06:26Z |
| format | Article |
| id | doaj.art-858814b56a2d414e8771c0aad3f8d4e2 |
| institution | Directory Open Access Journal |
| issn | 2047-783X |
| language | English |
| last_indexed | 2024-03-10T22:06:26Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | European Journal of Medical Research |
| spelling | doaj.art-858814b56a2d414e8771c0aad3f8d4e22023-11-19T12:47:27ZengBMCEuropean Journal of Medical Research2047-783X2023-10-012811710.1186/s40001-023-01372-4Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trialAhmed F. Elmahrouk0Mohammad S. Shihata1Osman O. AL-Radi2Amr A. Arafat3Musleh Altowaity4Bayan A. Alshaikh5Mohamed N. Galal6Abdulbadee A. Bogis7Haneen Y. Al Omar8Wesal J. Assiri9Ahmed A. Jamjoom10Cardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Cardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Cardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Cardiothoracic Surgery Department, Tanta UniversityCardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Cardiac Surgery Department, King Fahad Armed Forces HospitalPediatric Cardiac Surgery Department, King Fahad Armed Forces HospitalCardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Research Centre, King Faisal Specialist Hospital and Research CentreDepartment of Nursing, King Faisal Specialist Hospital and Research CentreCardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,Abstract Background Blood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery. Methods The study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%. Results Between January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2–Q3: 10–19) days in the CC group vs. 13 (10–21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6–7.45) vs. 5 (2.6–7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2–Q3: 18.73–41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55). Conclusions Custodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017https://doi.org/10.1186/s40001-023-01372-4CardioplegiaCustadiolBlood cardioplegiaHistidine-tryptophan-ketoglutarate |
| spellingShingle | Ahmed F. Elmahrouk Mohammad S. Shihata Osman O. AL-Radi Amr A. Arafat Musleh Altowaity Bayan A. Alshaikh Mohamed N. Galal Abdulbadee A. Bogis Haneen Y. Al Omar Wesal J. Assiri Ahmed A. Jamjoom Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial European Journal of Medical Research Cardioplegia Custadiol Blood cardioplegia Histidine-tryptophan-ketoglutarate |
| title | Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial |
| title_full | Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial |
| title_fullStr | Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial |
| title_full_unstemmed | Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial |
| title_short | Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial |
| title_sort | custodiol versus blood cardioplegia in pediatric cardiac surgery a randomized controlled trial |
| topic | Cardioplegia Custadiol Blood cardioplegia Histidine-tryptophan-ketoglutarate |
| url | https://doi.org/10.1186/s40001-023-01372-4 |
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