Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 10:58 PM
Study NCT ID:
NCT05221294
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'troponin I', 'timeFrame': '24 hours after surgery', 'description': 'troponin I at 24 hours after surgery to assess myocardial protection between the two used cardioplegia solutions.'}], 'secondaryOutcomes': [{'measure': 'The total volume of cardioplegia solution', 'timeFrame': 'In the first 24 hours of surgery', 'description': 'The total volume of cardioplegia solution'}, {'measure': 'Total cross-clamp time and total CPB time', 'timeFrame': 'In the first 24 hours of surgery', 'description': 'Total cross-clamp time and total CPB time'}, {'measure': 'Incidence of ventricular fibrillation after cross-camp removal', 'timeFrame': 'In the first 24 hours of surgery', 'description': 'side effects'}, {'measure': 'Postoperative left ventricular ejection fraction', 'timeFrame': '24 hours after surgery in days', 'description': 'Postoperative left ventricular ejection fraction'}, {'measure': 'Requirement of inotropes and time of discontinuation', 'timeFrame': 'postoperative 24 hours', 'description': 'intraoperative'}, {'measure': 'Troponin I at 12 hours after surgery', 'timeFrame': 'postoperative 24 hours', 'description': 'Troponin I at 12 hours after surgery'}, {'measure': 'CK-MB at 12 and 24 hours after surgery', 'timeFrame': '24 hours after surgery', 'description': 'assessment'}, {'measure': 'Serum lactate level at 24 hours after surgery.', 'timeFrame': '24 hours after surgery', 'description': 'assessment'}, {'measure': 'Incidence of postoperative AF and MI.', 'timeFrame': '24 hours after surgery', 'description': 'assessment'}, {'measure': 'Time for weaning from mechanical ventilation', 'timeFrame': '24 hours after surgery in hours', 'description': 'Time for weaning from mechanical ventilation'}, {'measure': 'ICU length of stay', 'timeFrame': '24 hours after surgery in days', 'description': 'assessment'}, {'measure': 'hospital length of stay', 'timeFrame': '24 hours after surgery in days', 'description': 'assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Protection', 'Custodiol Cardioplegia', 'Del Nido'], 'conditions': ['Cardioplegia Solution Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '30069192', 'type': 'RESULT', 'citation': 'Sanetra K, Pawlak I, Cisowski M. Del Nido cardioplegia - what is the current evidence? Kardiochir Torakochirurgia Pol. 2018 Jun;15(2):114-118. doi: 10.5114/kitp.2018.76477. Epub 2018 Jun 25.'}, {'pmid': '31204129', 'type': 'RESULT', 'citation': 'Vivacqua A, Robinson J, Abbas AE, Altshuler JM, Shannon FL, Podolsky RH, Sakwa MP. Single-dose cardioplegia protects myocardium as well as traditional repetitive dosing: A noninferiority randomized study. J Thorac Cardiovasc Surg. 2020 May;159(5):1857-1863.e1. doi: 10.1016/j.jtcvs.2019.03.125. Epub 2019 May 11.'}, {'pmid': '41081689', 'type': 'DERIVED', 'citation': 'Abdelhady MA, Goda AS, Sayed Gomaa MS, Hamed MA, Hassan AASM. Modified Del Nido Versus Custodiol(R) Cardioplegia for Myocardial Protection in Adult Patients Undergoing Cardiac Surgery; A Prospective Randomized Double-Blinded Clinical Trial. Ann Card Anaesth. 2025 Oct 1;28(4):451-458. doi: 10.4103/aca.aca_35_25. Epub 2025 Oct 13.'}]}, 'descriptionModule': {'briefSummary': "Cardioplegia solutions have been considered as a corner stone for myocardial protection during cardiac surgery with cardiopulmonary bypass and cardiac arrest, it limits the metabolic activity and increases the capacity of the myocardium to withstand prolonged ischemic time, and thus it has a direct impact on surgical outcomes. (1, 2) Long acting cardioplegic solutions with a single dose strategy are beneficial as they allow surgery without interruptions, reducing cross clamp time and provide more cardiac protection. (3) Custodiol (histidine- tryptophan- ketoglutarate) solution has been described in the 1970s by Bretschneider (4), and used as an alternative to hyperkalemic crystalloid solutions especially during complex cardiac surgeries, also used for organ preservation during transplant surgery. (5, 6) In the 1990s Pedro del Nido and his team introduced a new cardioplegic solution (del Nido cardioplegia) for pediatric cardiac surgeries. (7) But recently, many studies postulated its use for adults. (8) The base solution for the traditional del Nido cardioplegia is Plasma-Lyte A which is a calcium free solution and electrolyte composition similar to the extracellular fluid. (7) However Plasma-Lyte A is unavailable in many countries, this precludes its use. Some authors have advocated lactated Ringer's as a base solution instead of Plasma-Lyte A for preparing del Nido cardioplegia, now known as modified del Nido cardioplegia. (9) Custodiol and modified del Nido cardioplegia can be used in a single dose fashion with proper myocardial protection and minimal surgical interruptions. However, the literature also does not confirm the superiority of one over another. (1) Also, limited number of clinical trials compared both cardioplegic solutions directly. So, in this study we aimed to assess the efficacy of both Custodiol and modified del Nido cardioplegia in myocardial protection and clinical outcomes among adult patients undergoing cardiac surgery.", 'detailedDescription': "Patients will be divided into two groups with 1:1 allocation, randomized by computer generated random numbers that will be placed in separate opaque envelopes opened by study investigators at OR. MDN group (will receive modified Del Nido cardioplegia solution) and C group (will receive Custodiol cardioplegia). Participants and data collectors will be blinded with the group allocation till the end of the study.\n\nInclusion criteria: patients ≥ 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery.\n\nAll patients will be preoperatively examined and investigated by complete blood count, coagulation profile, liver and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested on demand.\n\nPatient will be premedicated by intramuscular injection of 10mg morphine at morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced by midazolam 2-5 mg, fentanyl (10μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).\n\nTrachea will be intubated; patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis and capnogram. An esophageal temperature probe and a urinary catheter will also be placed. For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein. Anesthesia will be maintained by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h for continued muscle relaxation. During extracorporeal circulation, patients will receive propofol infusion at a rate of 50-100 µ/kg/min. in addition to atracurium infusion.\n\nBefore initiation of cardiopulmonary bypass (CPB), the patients will receive intravenous heparin (300-500 units/kg body weight) to achieve an activated clotting time \\>480s. CPB will be instituted via an ascending aortic cannula and a two-stage right atrial cannula. Before, during (pump blood flow: 2.4l/min/m2), and after CPB, mean arterial pressure will be adjusted to exceed 60mmHg.\n\nSurgery will be done via median sternotomy; CBP will be established via arterial cannula in the ascending aorta and venous drainage obtained via two-stage cannula in the right atrium or bicaval cannulation.\n\nMyocardial protection:\n\nCardioplegic solution will be administered via antegrade technique through the aortic root or the coronary ostia accordingly. Patients will receive either Custodiol cardioplegia or modified Del Nido cardioplegia according to their allocation.\n\nReady Custodiol cardioplegia solution will be administered in a single dose of 25ml.kg-1 over 6-8 minutes with 4-8 oC temperature and 150-200 mmHg infusion pressure. Custodiol is a ready sterile cardioplegia composed of; sodium chloride 15 mmol/L, potassium chloride 9 mmol/L, magnesium chloride 4 mmol/L, calcium chloride 0.015 mmol/L, histidine 180 mmol/L, tryptophan 2 mmol/L, ketoglutarate 1 mmol/L and mannitol 30 mmol/L with pH 7.4-7.45 at 4°C and osmolality 310 mosmol/Kg.\n\nModified Del Nido cardioplegia will be prepared at OR, and lactated Ringer's solution will be used as a crystalloid base, with crystalloid: blood ratio of 4:1 and will be given with a dose of 20 ml/kg (with a maximum dose of 1000 ml) at 4 oC temperature and 200-300 mmHg administration pressure and if necessary additional dose will be given after 90 minutes of the initial dose. The composition of modified Del Nido cardioplegia will be as follows: lactated Ringer's solution 1000ml, 13 ml sodium bicarbonate (1 mEq/ ml), 16.3 ml of mannitol 20%, 4 ml magnesium 50%, 6.5 ml of lidocaine 2% and 13ml of potassium chloride (2 mEq/L)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥ 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Chronic kidney disease.\n* Hepatic impairment.\n* Re-do surgery.\n* Severe psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT05221294', 'briefTitle': 'Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University Hospital'}, 'officialTitle': 'Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Adult Patients Undergoing Cardiac Surgery; A Prospective Randomized Double-Blinded Clinical Trial.', 'orgStudyIdInfo': {'id': 'R193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDN group', 'description': 'will receive modified Del Nido cardioplegia solution', 'interventionNames': ['Drug: Modified Del Nido Versus Custodiol Cardioplegia']}, {'type': 'EXPERIMENTAL', 'label': 'C group', 'description': 'will receive Custodiol cardioplegia', 'interventionNames': ['Drug: Modified Del Nido Versus Custodiol Cardioplegia']}], 'interventions': [{'name': 'Modified Del Nido Versus Custodiol Cardioplegia', 'type': 'DRUG', 'description': 'Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Cardiac Surgery', 'armGroupLabels': ['C group', 'MDN group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'state': 'Faiyum Governorate', 'country': 'Egypt', 'facility': 'Fayoum University hospital', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'Mohamed Hamed, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fayoum University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fayoum University Hospital', 'investigatorFullName': 'Mahdy Ahmed Abd Elhady', 'investigatorAffiliation': 'Fayoum University Hospital'}}}}