Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery
2. august 2021 oppdatert av: Daniel Stromberg, University of Texas at Austin
Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow the surgeon to perform heart operations. However, these processes can cause injury to the heart which may worsen post-operative outcomes. In fact, the effects of these injuries may continue after surgery, and lead to a long-term decrease in heart function. Neonates and young infants are at particular risk for this occurrence.
While much research has been done in adults looking for medicines that might protect the heart during surgery, few studies have been conducted in neonates and young infants. The investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric cancer patients, in the hope that it may lessen cardiac injury during and after congenital heart surgery, and thereby improve outcomes in the neonatal and young infant population.
In order to accomplish this, the investigators must first determine how Dexrazoxane can be safely administered to young children with congenital heart disease.
Studieoversikt
Detaljert beskrivelse
Neonates and infants undergoing heart surgery with cardiopulmonary bypass and cardioplegic arrest experience both inflammation and myocardial ischemia-reperfusion [IR] injury. These processes provoke myocardial apoptosis and oxygen free radical formation which result in cardiac injury and dysfunction. Dexrazoxane [DRZ] is a derivative of EDTA that is approved for prevention of anthracycline-related cardiotoxicity. It provides cardioprotection through reduction of toxic reactive oxygen species [ROS], and suppression of apoptosis.
The investigators propose a 12-patient pilot to determine DRZ pharmacokinetics, and to collect additional safety data in the neonatal and infant population. Efficacy of cardioprotection will not be evaluated in this preliminary investigation, though the investigators will determine postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, laboratory indices of myocardial injury and systemic inflammation, and echocardiographic cardiac dysfunction for safety purposes, and as a run-in to the larger, randomized, placebo controlled trial. Conducting this pilot could optimize team execution of the study protocol. In addition, results could further establish the safety of DRZ in the neonatal and infant populations.
Studietype
Intervensjonell
Registrering (Forventet)
12
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Daniel Stromberg, MD
- Telefonnummer: 512-324-3357
- E-post: dstromberg@austin.utexas.edu
Studer Kontakt Backup
- Navn: Jacob Strelow, MPH
- Telefonnummer: 757-268-2691
- E-post: strelow.jacob@austin.utexas.edu
Studiesteder
-
-
Texas
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Austin, Texas, Forente stater, 78723
- Rekruttering
- Dell Children's Medical Center of Central Texas
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 sekund til 1 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age ≤ 1 year
- open heart surgery requiring CPB and use of cardioplegia
- parent/guardian consent for study obtained
- surgery planned Monday-Friday
Exclusion Criteria:
- gestational age <36 weeks at time of enrollment
- known syndrome or genetic abnormality, except Trisomy 21
- single ventricle physiology
- concurrent enrollment in another research protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Dexrazoxane
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Twelve enrollees will be consecutively assigned to a dosing regimen of 400 mg/m2/dose.
The medication will be administered in the operating room 30 minutes prior to starting cardiopulmonary bypass (dose #1), prior to aortic cross clamp removal (dose #2), and on the morning after surgery in the cardiac intensive care unit (dose #3).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maksimal plasmakonsentrasjon (Cmax)
Tidsramme: 24 timer
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24 timer
|
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Area under the plasma concentration vs time curve (AUC)
Tidsramme: 24 hours
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24 hours
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Minimum plasma concentration (Cmin)
Tidsramme: 24 hours
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24 hours
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Time to resolution of organ failure
Tidsramme: 14 days
|
defined as hours to the point of being off invasive mechanical ventilation, without significant renal dysfunction [cystatin C within normal range for age, and UOP > 1 cc/kg/hr], and off significant inotropic support [defined as milrinone >0.3 mcg/kg/min, dopamine >3 mcg/kg/min, dobutamine >3 mcg/kg/min, any combination of these inotropes, or any epinephrine, norepinephrine, phenylephrine or vasopressin)] with a serum lactate <2 mmol/L.
One point will be awarded for each postoperative hour of continued organ dysfunction up to postoperative hour 336 (day 14).
A score of 360 will be assigned if organ failure is not resolved by postoperative day 14, or if the patient requires mechanical circulatory support or experiences mortality.
This variable has been chosen to allow for recognition of early drug effects, and those which might be delayed beyond the immediate postoperative period.
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14 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Myocardial Injury
Tidsramme: 7 days
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determined by elevated serum cardiac troponin
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7 days
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Oxidative Stress
Tidsramme: 3 days
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measured by lipoperoxidation (serum F2 isoprostane)
|
3 days
|
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Inflammatory activation (IL-6 and IL-10)
Tidsramme: 3 days
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3 days
|
|
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Neurologic IR injury
Tidsramme: 3 days
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measured by serum activin A concentration
|
3 days
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ICU Length of Stay
Tidsramme: 60 days
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60 days
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Hospital Length of Stay
Tidsramme: 60 days
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60 days
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Tei Index (via echocardiogram)
Tidsramme: 60 days
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the sum of the isovolumic contraction and relaxation times divided by the ejection time
|
60 days
|
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Ventricular ejection fraction (via echocardiogram)
Tidsramme: 60 days
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the volumetric fraction of fluid ejected from a chamber with each contraction
|
60 days
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Tissue doppler E/E' ratio (via echocardiogram)
Tidsramme: 60 days
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calculated as E wave divided by e' velocities
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60 days
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Composite outcome for neonatal cardiac surgery
Tidsramme: 60 days
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(per Graham, EM, et al) - binary variable defined as death, use of mechanical circulatory support, cardiac arrest requiring chest compressions, hepatic injury [2 times the upper limit of normal for AST or ALT], renal injury [Cr >1.5 mg/dL], or lactic acidosis [an increasing lactate >5 mmol/L in the postoperative period]
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60 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- Zheng H, Dimayuga C, Hudaihed A, Katz SD. Effect of dexrazoxane on homocysteine-induced endothelial dysfunction in normal subjects. Arterioscler Thromb Vasc Biol. 2002 Jul 1;22(7):E15-8. doi: 10.1161/01.atv.0000023187.25914.5b.
- Junjing Z, Yan Z, Baolu Z. Scavenging effects of dexrazoxane on free radicals. J Clin Biochem Nutr. 2010 Nov;47(3):238-45. doi: 10.3164/jcbn.10-64. Epub 2010 Oct 29.
- Popelova O, Sterba M, Haskova P, Simunek T, Hroch M, Guncova I, Nachtigal P, Adamcova M, Gersl V, Mazurova Y. Dexrazoxane-afforded protection against chronic anthracycline cardiotoxicity in vivo: effective rescue of cardiomyocytes from apoptotic cell death. Br J Cancer. 2009 Sep 1;101(5):792-802. doi: 10.1038/sj.bjc.6605192. Epub 2009 Jul 21.
- Zhou L, Sung RY, Li K, Pong NH, Xiang P, Shen J, Ng PC, Chen Y. Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. Int J Cardiol. 2011 Oct 20;152(2):196-201. doi: 10.1016/j.ijcard.2010.07.015. Epub 2010 Aug 6.
- Spagnuolo RD, Recalcati S, Tacchini L, Cairo G. Role of hypoxia-inducible factors in the dexrazoxane-mediated protection of cardiomyocytes from doxorubicin-induced toxicity. Br J Pharmacol. 2011 May;163(2):299-312. doi: 10.1111/j.1476-5381.2011.01208.x.
- Hasinoff BB, Schroeder PE, Patel D. The metabolites of the cardioprotective drug dexrazoxane do not protect myocytes from doxorubicin-induced cytotoxicity. Mol Pharmacol. 2003 Sep;64(3):670-8. doi: 10.1124/mol.64.3.670.
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- Brier ME, Gaylor SK, McGovren JP, Glue P, Fang A, Aronoff GR. Pharmacokinetics of dexrazoxane in subjects with impaired kidney function. J Clin Pharmacol. 2011 May;51(5):731-8. doi: 10.1177/0091270010369675. Epub 2010 May 19.
- Elbl L, Hrstkova H, Tomaskova I, Michalek J. Late anthracycline cardiotoxicity protection by dexrazoxane (ICRF-187) in pediatric patients: echocardiographic follow-up. Support Care Cancer. 2006 Feb;14(2):128-36. doi: 10.1007/s00520-005-0858-8. Epub 2005 Jul 21.
- Sanchez-Medina J, Gonzalez-Ramella O, Gallegos-Castorena S. The effect of dexrazoxane for clinical and subclinical cardiotoxicity in children with acute myeloid leukemia. J Pediatr Hematol Oncol. 2010 May;32(4):294-7. doi: 10.1097/MPH.0b013e3181d321b3.
- Choi HS, Park ES, Kang HJ, Shin HY, Noh CI, Yun YS, Ahn HS, Choi JY. Dexrazoxane for preventing anthracycline cardiotoxicity in children with solid tumors. J Korean Med Sci. 2010 Sep;25(9):1336-42. doi: 10.3346/jkms.2010.25.9.1336. Epub 2010 Aug 12.
- Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500. doi: 10.1200/JCO.2005.02.3879.
- Barry EV, Vrooman LM, Dahlberg SE, Neuberg DS, Asselin BL, Athale UH, Clavell LA, Larsen EC, Moghrabi A, Samson Y, Schorin MA, Cohen HJ, Lipshultz SE, Sallan SE, Silverman LB. Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane. J Clin Oncol. 2008 Mar 1;26(7):1106-11. doi: 10.1200/JCO.2007.12.2481.
- Lipshultz SE, Scully RE, Lipsitz SR, Sallan SE, Silverman LB, Miller TL, Barry EV, Asselin BL, Athale U, Clavell LA, Larsen E, Moghrabi A, Samson Y, Michon B, Schorin MA, Cohen HJ, Neuberg DS, Orav EJ, Colan SD. Assessment of dexrazoxane as a cardioprotectant in doxorubicin-treated children with high-risk acute lymphoblastic leukaemia: long-term follow-up of a prospective, randomised, multicentre trial. Lancet Oncol. 2010 Oct;11(10):950-61. doi: 10.1016/S1470-2045(10)70204-7. Epub 2010 Sep 16.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. april 2021
Primær fullføring (Forventet)
1. oktober 2021
Studiet fullført (Forventet)
1. januar 2022
Datoer for studieregistrering
Først innsendt
21. juli 2021
Først innsendt som oppfylte QC-kriteriene
2. august 2021
Først lagt ut (Faktiske)
9. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Kardiovaskulære abnormiteter
- Medfødte abnormiteter
- Hjertefeil, medfødt
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Antimitotiske midler
- Mitosemodulatorer
- Beskyttende agenter
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Kardiotoniske midler
- Dexrazoxane
- Razoxane
Andre studie-ID-numre
- 2020-02-0075
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .