Congenital Heart DiseasePhase 2NCT03082716
Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
A Phase 2 study testing Custodiol Solution and Blood cardioplegia in people with Congenital Heart Disease, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Custodiol Solution and Blood cardioplegia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Mar 2016to 29 Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .
Who cannot join
- All emergency procedure( require immediate surgery)
- Cases that don't require use of cardioplegia .
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre
Jeddah, Western, 40047
About this study
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .
Read the detailed description
Hypothesis :
Custodial is not inferior to blood cardioplegia in myocardial protection in paediatric cardiac surgery ..
Methodology :
Study design :
Randomized controlled trial
Data collection:
All demographic data ,diagnosis ,procedure(type.CPB time ,crossclamp time) , surgeon and hospital course details .
Computer generated randomisation into two groups based on cardioplegia solution .
if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested..
Blinding :
Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .
Sample size calculated with an online calculator based on α error of 0.05 and β error of 0.2 to detect an absolute risk difference of 15% in composite end point between the two groups yielded 137 in each arm ,The results will be presented as mean (SD), median (interquartile range), or proportion . Using relative risk and log rank for statistical analysis .A P value of less than 0.05 will be considered statistically significant. Statistical analyses will be carried out using the SPSS .
Safety monitoring and interim results :
Both cardioplegia solutions are already in use and FDA approved there is no safety concerns at the time being . However , an interim analysis will be carried on every 6 months and the principal investigator will decide weather to stop or carry on if any major discrepancies in outcomes
literature review : After an extensive literature review the investigators found only one randomised trial by elmorsy et al , which concluded that A single dose of an HTK cardioplegic solution provides better myocardial and cerebral protection than repeated doses of oxygenated blood cardioplegia during pediatric congenital cardiac surgery.
On the other hand there was another retrospective report by bojan et al, found that The use of Custodiol cardioplegia in neonates undergoing ASO was associated with a larger troponin release when compared with warm blood cardioplegia,p <0.001 suggesting poor myocardial protection.
koruon et al, done a tissue level comparison between htk and conventional crystalloid cardioplegia and their statistical analysis revealed no significant difference between the two groups regarding the clinical variables, apoptotic indices and proliferation indices.
Liu j et al ,did a retrospective study comparing custodiol to St. Thomas crystalloid cardioplegia which concluded That HTK group had shorter cross-clamping time and more frequent spontaneous defibrillation than St. Thomas group.
Also an animal study by Chen Y et al, on piglets that were randomised to either a single dose of HTK or multidose cold blood cardioplegia .. No significant differences were noted in the myocardial lactate content, ATP content, and histopathological score between both groups .
Finally a retrospective report by E Qulisy et al concluded that Custodiol cardioplegia is associated with less myocardial protection and higher adverse outcomes compared to blood cardioplegia in pediatric age group undergoing cardiac surgery.
- Conditions
- Congenital Heart Disease
- Being tested
- Custodiol Solution, Blood cardioplegia
- Keywords
- cardioplegia, myocardial protection, custodiol, htk
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol SolutionDrug
Also called htk
After cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
Blood cardioplegiaDrug
After cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| blood cardioplegia group | Active comparator | patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. Receives: Drug: Blood cardioplegia |
| custodiol group | Experimental | patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested. Receives: Drug: Custodiol Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (yes/no)
Death of all causes
Measured: up to 30 days
ICU stay (days)
length of ICU stay
Measured: up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death)
Arrhythmia (yes/no)
post operative arrythmia that required intervention
Measured: up to 48 hours
Secondary outcomes (7)
length of stay (days)
Measured: up to 90 days (length of the hospital stay required since admission recorded by days until discharge or death )
length of mechanical ventilation (hours)
Measured: up to 5 days
myocardial biomarkers
(troponin and CKMB) measured (preoperatively,postoperatively 6h,24h,48h,)
Measured: up to 5 days
Subjective ventricular function (normal,mildly depressed ,moderately depressed ,moderately-severe depressed ,severly depressed )
assessed by a cardiologist subjective assessment of the echocardiographically (preoperative ,immediate post repair ,24h post operative )
Measured: up to 24 hours
Ejection fraction (percentage)
assessed by echocardiography (preoperative ,immediate post repair ,24h post operative )
Measured: up to 24 hours
ECMO support (yes/no)
Measured: intraoperative
vasoactive inotropic score ( low or high)
Vasoactive Inotropic score : (all doses of inotropes recorded hourly during 48 h)
Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) +100 × epinephrine dose (μg/kg/min)+ 10 X Milrinone dose (μg/kg/min) +10,000 × Vasopressin dose (U/kg/min) + 100 × Norepinephrine dose (μg/kg/min)
calculated hourly for 48 hours and added than divided by 48 to give the score . if maximum score < 20 its low VIS and if maximum score ≥ 20 its a high VIS
Measured: up to 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start16 Mar 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation : Computer generated randomisation into two groups based on cardioplegia solution . if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082716
- Sponsor's protocol ID
- IRB 2016-08 Custodiol Study
- Status last verified
- Apr 2023
- First submitted
- 29 Jan 2017
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kotani Y, Tweddell J, Gruber P, Pizarro C, Austin EH 3rd, Woods RK, Gruenwald C, Caldarone CA. Current cardioplegia practice in pediatric cardiac surgery: a North American multiinstitutional survey. Ann Thorac Surg. 2013 Sep;96(3):923-9. doi: 10.1016/j.athoracsur.2013.05.052. Epub 2013 Jul 31.
PubMed 23915588Harvey B, Shann KG, Fitzgerald D, Mejak B, Likosky DS, Puis L, Baker RA, Groom RC; American Society of ExtraCorporeal Technology's International Consortium for Evidence-Based Perfusion and Pediatric Perfusion Committee. International pediatric perfusion practice: 2011 survey results. J Extra Corpor Technol. 2012 Dec;44(4):186-93.
PubMed 23441558Korun O, Ozkan M, Terzi A, Askin G, Sezgin A, Aslamaci S. The comparison of the effects of Bretschneider's histidine-tryptophan-ketoglutarate and conventional crystalloid cardioplegia on pediatric myocardium at tissue level. Artif Organs. 2013 Jan;37(1):76-81. doi: 10.1111/j.1525-1594.2012.01575.x.
PubMed 23305576elmorsy et al , Does type of cardioplegia affect myocardial and cerebral outcome in pediatric open cardiac surgeries? Ain-Shams Journal of Anesthesiology ,2014; 2(7) :242-249
Bojan M, Peperstraete H, Lilot M, Tourneur L, Vouhe P, Pouard P. Cold histidine-tryptophan-ketoglutarate solution and repeated oxygenated warm blood cardioplegia in neonates with arterial switch operation. Ann Thorac Surg. 2013 Apr;95(4):1390-6. doi: 10.1016/j.athoracsur.2012.12.025. Epub 2013 Feb 22.
PubMed 23462260Liu J, Feng Z, Zhao J, Li B, Long C. The myocardial protection of HTK cardioplegic solution on the long-term ischemic period in pediatric heart surgery. ASAIO J. 2008 Sep-Oct;54(5):470-3. doi: 10.1097/MAT.0b013e318188b86c.
PubMed 18812735Chen Y, Liu J, Li S, Li W, Yan F, Sun P, Wang H, Long C. Which is the better option during neonatal cardiopulmonary bypass: HTK solution or cold blood cardioplegia? ASAIO J. 2013 Jan-Feb;59(1):69-74. doi: 10.1097/MAT.0b013e3182798524.
PubMed 23263337Custodiol versus blood cardioplegia in pediatric cardiac surgery. SHAJ .October 2015 ;27,(4):327
Elmahrouk AF, Shihata MS, Al-Radi OO, Arafat AA, Altowaity M, Alshaikh BA, Galal MN, Bogis AA, Al Omar HY, Assiri WJ, Jamjoom AA. Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial. Eur J Med Res. 2023 Oct 5;28(1):404. doi: 10.1186/s40001-023-01372-4.
PubMed 37798628
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03082716
- Acronym / sponsor ID
- IRB 2016-08 Custodiol Study
- Conditions
- Congenital Heart Disease
- Keywords
- cardioplegia, myocardial protection, custodiol, htk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .
Detailed description
Hypothesis :
Custodial is not inferior to blood cardioplegia in myocardial protection in paediatric cardiac surgery ..
Methodology :
Study design :
Randomized controlled trial
Data collection:
All demographic data ,diagnosis ,procedure(type.CPB time ,crossclamp time) , surgeon and hospital course details .
Computer generated randomisation into two groups based on cardioplegia solution .
if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested..
Blinding :
Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .
Sample size calculated with an online calculator based on α error of 0.05 and β error of 0.2 to detect an absolute risk difference of 15% in composite end point between the two groups yielded 137 in each arm ,The results will be presented as mean (SD), median (interquartile range), or proportion . Using relative risk and log rank for statistical analysis .A P value of less than 0.05 will be considered statistically significant. Statistical analyses will be carried out using the SPSS .
Safety monitoring and interim results :
Both cardioplegia solutions are already in use and FDA approved there is no safety concerns at the time being . However , an interim analysis will be carried on every 6 months and the principal investigator will decide weather to stop or carry on if any major discrepancies in outcomes
literature review : After an extensive literature review the investigators found only one randomised trial by elmorsy et al , which concluded that A single dose of an HTK cardioplegic solution provides better myocardial and cerebral protection than repeated doses of oxygenated blood cardioplegia during pediatric congenital cardiac surgery.
On the other hand there was another retrospective report by bojan et al, found that The use of Custodiol cardioplegia in neonates undergoing ASO was associated with a larger troponin release when compared with warm blood cardioplegia,p <0.001 suggesting poor myocardial protection.
koruon et al, done a tissue level comparison between htk and conventional crystalloid cardioplegia and their statistical analysis revealed no significant difference between the two groups regarding the clinical variables, apoptotic indices and proliferation indices.
Liu j et al ,did a retrospective study comparing custodiol to St. Thomas crystalloid cardioplegia which concluded That HTK group had shorter cross-clamping time and more frequent spontaneous defibrillation than St. Thomas group.
Also an animal study by Chen Y et al, on piglets that were randomised to either a single dose of HTK or multidose cold blood cardioplegia .. No significant differences were noted in the myocardial lactate content, ATP content, and histopathological score between both groups .
Finally a retrospective report by E Qulisy et al concluded that Custodiol cardioplegia is associated with less myocardial protection and higher adverse outcomes compared to blood cardioplegia in pediatric age group undergoing cardiac surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation : Computer generated randomisation into two groups based on cardioplegia solution . if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
| Arm | Type | Receives |
|---|---|---|
| blood cardioplegia group | Active comparator | Drug: Blood cardioplegiapatient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. |
| custodiol group | Experimental | Drug: Custodiol Solutionpatient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .
Key exclusion criteria (2 listed)
- All emergency procedure( require immediate surgery)
- Cases that don't require use of cardioplegia .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custodiol SolutionAlso: htkAfter cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested. | Drug | custodiol group |
| Blood cardioplegiaAfter cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. | Drug | blood cardioplegia group |
Primary outcome
Mortality (yes/no)
Time frame: up to 30 days
Death of all causes
ICU stay (days)
Time frame: up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death)
length of ICU stay
Arrhythmia (yes/no)
Time frame: up to 48 hours
post operative arrythmia that required intervention
7 secondary outcomes
length of stay (days)
Time frame: up to 90 days (length of the hospital stay required since admission recorded by days until discharge or death )
length of mechanical ventilation (hours)
Time frame: up to 5 days
myocardial biomarkers
Time frame: up to 5 days
Subjective ventricular function (normal,mildly depressed ,moderately depressed ,moderately-severe depressed ,severly depressed )
Time frame: up to 24 hours
Ejection fraction (percentage)
Time frame: up to 24 hours
ECMO support (yes/no)
Time frame: intraoperative
vasoactive inotropic score ( low or high)
Time frame: up to 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 23915588Kotani Y, Tweddell J, Gruber P, Pizarro C, Austin EH 3rd, Woods RK, Gruenwald C, Caldarone CA. Current cardioplegia practice in pediatric cardiac surgery: a North American multiinstitutional survey. Ann Thorac Surg. 2013 Sep;96(3):923-9. doi: 10.1016/j.athoracsur.2013.05.052. Epub 2013 Jul 31.
- Background: PubMed 23441558Harvey B, Shann KG, Fitzgerald D, Mejak B, Likosky DS, Puis L, Baker RA, Groom RC; American Society of ExtraCorporeal Technology's International Consortium for Evidence-Based Perfusion and Pediatric Perfusion Committee. International pediatric perfusion practice: 2011 survey results. J Extra Corpor Technol. 2012 Dec;44(4):186-93.
- Background: PubMed 23305576Korun O, Ozkan M, Terzi A, Askin G, Sezgin A, Aslamaci S. The comparison of the effects of Bretschneider's histidine-tryptophan-ketoglutarate and conventional crystalloid cardioplegia on pediatric myocardium at tissue level. Artif Organs. 2013 Jan;37(1):76-81. doi: 10.1111/j.1525-1594.2012.01575.x.
- Backgroundelmorsy et al , Does type of cardioplegia affect myocardial and cerebral outcome in pediatric open cardiac surgeries? Ain-Shams Journal of Anesthesiology ,2014; 2(7) :242-249
- Results publication: PubMed 23462260Bojan M, Peperstraete H, Lilot M, Tourneur L, Vouhe P, Pouard P. Cold histidine-tryptophan-ketoglutarate solution and repeated oxygenated warm blood cardioplegia in neonates with arterial switch operation. Ann Thorac Surg. 2013 Apr;95(4):1390-6. doi: 10.1016/j.athoracsur.2012.12.025. Epub 2013 Feb 22.
- Results publication: PubMed 18812735Liu J, Feng Z, Zhao J, Li B, Long C. The myocardial protection of HTK cardioplegic solution on the long-term ischemic period in pediatric heart surgery. ASAIO J. 2008 Sep-Oct;54(5):470-3. doi: 10.1097/MAT.0b013e318188b86c.
- Results publication: PubMed 23263337Chen Y, Liu J, Li S, Li W, Yan F, Sun P, Wang H, Long C. Which is the better option during neonatal cardiopulmonary bypass: HTK solution or cold blood cardioplegia? ASAIO J. 2013 Jan-Feb;59(1):69-74. doi: 10.1097/MAT.0b013e3182798524.
- Results publicationCustodiol versus blood cardioplegia in pediatric cardiac surgery. SHAJ .October 2015 ;27,(4):327
- Derived from this study: PubMed 37798628Elmahrouk AF, Shihata MS, Al-Radi OO, Arafat AA, Altowaity M, Alshaikh BA, Galal MN, Bogis AA, Al Omar HY, Assiri WJ, Jamjoom AA. Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial. Eur J Med Res. 2023 Oct 5;28(1):404. doi: 10.1186/s40001-023-01372-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Custodiol Solution and Blood cardioplegia in people with Congenital Heart Disease, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (yes/no) (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082716, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.