In short
This article discusses a clinical trial investigating the use of Citric Acid Monohydrate as a component in cardioplegia solutions for major heart surgery. The study compares two types of cardioplegia: Custodiol crystalloid cardioplegia and Buckberg blood cardioplegia, to evaluate their effectiveness in protecting the heart during surgeries with prolonged aortic clamping times.
At a glance
- Study Type
- Phase IV clinical trial, single-blind, prospective, longitudinal, randomized intervention
- Comparison
- Custodiol crystalloid cardioplegia vs. Buckberg blood cardioplegia
- Primary Outcome
- Composite of death, perioperative AMI, low cardiac output, AKIN-III kidney failure within 90 days
- Key Secondary Outcomes
- Troponin levels, 90-day mortality, need for blood transfusions, neurological complications
- Inclusion Criteria
- Adults (18+) needing major cardiac surgery with extracorporeal circulation and aortic clamping
- Key Exclusion Criteria
- Aortic arch procedures, hypothermia <28°C, active endocarditis, isolated aortic valve replacements
- Follow-up Period
- 90 days post-surgery
- Data Sharing
- De-identified data available 3 months to 5 years after publication
What is Citric Acid Monohydrate?
Citric acid monohydrate is a chemical compound that plays a crucial role in various medical applications. It's an important ingredient in cardioplegia solutions, which are used during heart surgeries. This compound is also known by several other names, including:
- Citric acid monohydrate (E 330)
- 2-hydroxy-1,2,3-propane-tricarboxylic acid, monohydrate
- Acidum citricum monohydricum
- Citric acid hydrate
These alternative names might be used in medical literature or on product labels, but they all refer to the same substance.
Use in Cardioplegia Solutions
Citric acid monohydrate is one of several components in a medical product called "Cardi-Braun Mantenimiento solución para perfusión," which is a cardioplegia solution. Cardioplegia solutions are special fluids used during heart surgeries to temporarily stop the heart in a controlled manner, allowing surgeons to perform delicate procedures.
The solution containing citric acid monohydrate is classified under the ATC code B05XA16, which stands for "Cardioplegia Solutions". This classification indicates its specific use in heart-related medical procedures.
Medical Conditions Treated
While citric acid monohydrate itself doesn't directly treat a specific condition, it's a crucial component in solutions used during cardiovascular surgeries. The clinical trial mentioned in the source focuses on patients undergoing major cardiac surgery with extracorporeal circulation. This type of surgery is typically performed to treat various heart conditions that require significant interventions.
Clinical Trial Overview
A clinical trial named "CARDIO-HEART" is being conducted to evaluate the impact of different types of cardioplegia solutions in patients undergoing major cardiac surgery. This trial is comparing two types of cardioplegia:
- Custodiol crystalloid cardioplegia
- Buckberg blood cardioplegia
The study aims to demonstrate that Custodiol crystalloid cardioplegia is not inferior to Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation and prolonged aortic clamping times.
Patient Eligibility
The trial has specific criteria for patient participation:
Inclusion criteria:
- Patients over 18 years of age
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping
Exclusion criteria:
- Aortic arch procedures
- Procedures where hypothermia below 28°C is expected during the intervention
- Minimally invasive "Port Access" procedures
- Active endocarditis
- Emerging procedures
- Isolated aortic valve replacements
Study Objectives and Endpoints
The primary objective of the study is to compare the occurrence of certain events between patients receiving Custodiol crystalloid cardioplegia and those receiving Buckberg blood cardioplegia. These events include:
- Death
- Perioperative AMI (Acute Myocardial Infarction, a heart attack that occurs during or shortly after surgery)
- Low cardiac postoperative output requiring ionotropic drugs
- AKIN-III acute kidney failure (Acute Kidney Injury Network stage III, a severe form of sudden kidney damage)
The study will also look at several secondary endpoints, including:
- Levels of Troponin I US (a protein that indicates heart muscle damage) at 12 and 24 hours after the procedure
- 90-day postoperative mortality
- Need for blood transfusions
- Incidence of postoperative atrial fibrillation (an irregular heart rhythm)
- Overall survival at 90 days
Potential Benefits and Risks
While the study doesn't explicitly state the potential benefits and risks, patients participating in this trial may contribute to improving cardiac surgery procedures. The comparison between different cardioplegia solutions could lead to better outcomes for future patients undergoing major heart surgeries.
However, as with any major surgical procedure, there are risks involved. These may include complications related to the surgery itself, as well as potential side effects or reactions to the cardioplegia solutions used. Patients considering participation in this trial should discuss these potential risks and benefits thoroughly with their healthcare providers.