Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Oct 5;28(1):404.
doi: 10.1186/s40001-023-01372-4.

Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial

Ahmed F Elmahrouk  1   2 , Mohammad S Shihata  3 , Osman O Al-Radi  3   4 , Amr A Arafat  5 , Musleh Altowaity  3 , Bayan A Alshaikh  6 , Mohamed N Galal  7 , Abdulbadee A Bogis  3 , Haneen Y Al Omar  8 , Wesal J Assiri  9 , Ahmed A Jamjoom  3
Affiliations
Randomized Controlled Trial

Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial

Ahmed F Elmahrouk et al. Eur J Med Res. .

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.

Keywords: Blood cardioplegia; Cardioplegia; Custadiol; Histidine-tryptophan-ketoglutarate.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Change in troponin levels in patients with Custodiol (Group 1) vs. blood cardioplegia (Group 2)
Fig. 3
Fig. 3
Kaplan–Meier survival curve of patients with Custodiol (Group 1) vs. blood cardioplegia (Group 2)
See this image and copyright information in PMC

References

    1. Poncelet AJ, van Steenberghe M, Moniotte S, Detaille T, Beauloye C, Bertrand L, et al. Cardiac and neurological assessment of normothermia/warm blood cardioplegia vs hypothermia/cold crystalloid cardioplegia in pediatric cardiac surgery: insight from a prospective randomized trial. Eur J cardio-thoracic Surg Off J Eur Assoc Cardio-thoracic Surg. 2011;40(6):1384–1390. doi: 10.1016/j.ejcts.2011.03.047. - DOI - PubMed
    1. Attia AA, Torky MAE, Abo Elnasr MM, Wahby EAE, Taha AEM. Cardioprotective effect of propofol in cardioplegia compared to systemic propofol in heart valves surgery; a randomized controlled trial. Cardiothorac Surg. 2023;31(1):14. doi: 10.1186/s43057-023-00103-z. - DOI
    1. Arafat AA, Hassan E, Alfonso JJ, Alanazi E, Alshammari AS, Mahmood A, et al. Del Nido versus warm blood cardioplegia in adult patients with a low ejection fraction. Cardiothorac Surg. 2021;29(1):24. doi: 10.1186/s43057-021-00061-4. - DOI
    1. Kato Y, Hattori K, Motoki M, Takahashi Y, Kotani S, Nishimura S, et al. Optimal results of aortic valve replacement with small mechanical valves (< 19 mm) J Heart Valve Dis. 2013;22(4):468–475. - PubMed
    1. Preusse CJ. Custodiol cardioplegia: a single-dose hyperpolarizing solution. J Extra Corpor Technol. 2016;48(2):P15–20. - PMC - PubMed

Publication types

Associated data