Cardioplegia Solution Adverse Reaction Clinical Trial
Official title:
Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Adult Patients Undergoing Cardiac Surgery; A Prospective Randomized Double-Blinded Clinical Trial.
NCT number | NCT05221294 |
Other study ID # | R193 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | November 30, 2023 |
Verified date | October 2022 |
Source | Fayoum University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - patients = 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery. Exclusion Criteria: - Emergency surgery. - Chronic kidney disease. - Hepatic impairment. - Re-do surgery. - Severe psychiatric illness. |
Country | Name | City | State |
---|---|---|---|
Egypt | Fayoum University hospital | Fayoum | Faiyum Governorate |
Lead Sponsor | Collaborator |
---|---|
Fayoum University Hospital |
Egypt,
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. — View 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):1857-186 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | troponin I | troponin I at 24 hours after surgery to assess myocardial protection between the two used cardioplegia solutions. | 24 hours after surgery | |
Secondary | The total volume of cardioplegia solution | The total volume of cardioplegia solution | In the first 24 hours of surgery | |
Secondary | Total cross-clamp time and total CPB time | Total cross-clamp time and total CPB time | In the first 24 hours of surgery | |
Secondary | Incidence of ventricular fibrillation after cross-camp removal | side effects | In the first 24 hours of surgery | |
Secondary | Postoperative left ventricular ejection fraction | Postoperative left ventricular ejection fraction | 24 hours after surgery in days | |
Secondary | Requirement of inotropes and time of discontinuation | intraoperative | postoperative 24 hours | |
Secondary | Troponin I at 12 hours after surgery | Troponin I at 12 hours after surgery | postoperative 24 hours | |
Secondary | CK-MB at 12 and 24 hours after surgery | assessment | 24 hours after surgery | |
Secondary | Serum lactate level at 24 hours after surgery. | assessment | 24 hours after surgery | |
Secondary | Incidence of postoperative AF and MI. | assessment | 24 hours after surgery | |
Secondary | Time for weaning from mechanical ventilation | Time for weaning from mechanical ventilation | 24 hours after surgery in hours | |
Secondary | ICU length of stay | assessment | 24 hours after surgery in days | |
Secondary | hospital length of stay | assessment | 24 hours after surgery in days |
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