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Citric Acid Monohydrate

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.

Table of Contents

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[1]. 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[1].

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[1]. 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”[1]. 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[1]. 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[1]. This trial is comparing two types of cardioplegia:

  1. Custodiol crystalloid cardioplegia
  2. 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[1].

Patient Eligibility

The trial has specific criteria for patient participation[1]:

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[1]:

  • 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[1]:

  • 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[1].

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[1].

Aspect Details
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

FAQ

  • What is the purpose of using Citric Acid Monohydrate in cardioplegia solutions? Citric Acid Monohydrate is used in cardioplegia solutions to help maintain the proper pH balance and provide energy to the heart cells during surgery. It's part of a carefully formulated solution designed to protect the heart while it's not receiving its normal blood supply.
  • What types of cardioplegia are being compared in this clinical trial? The trial compares two types of cardioplegia: Custodiol crystalloid cardioplegia and Buckberg blood cardioplegia. Both contain Citric Acid Monohydrate as one of their components.
  • Who can participate in this clinical trial? Participants must be over 18 years old and have a cardiac condition requiring major cardiac surgery with extracorporeal circulation and aortic clamping. However, there are several exclusion criteria, such as aortic arch procedures or active endocarditis.
  • What are the main outcomes the researchers are looking at? The primary outcome is a composite of death, perioperative heart attack, low cardiac output requiring drugs, and severe kidney failure within 90 days after surgery. Secondary outcomes include measures like troponin levels, need for blood transfusions, and overall survival at 90 days.
  • How long will the study follow the participants? The study will follow participants for 90 days after their surgery to assess various outcomes and complications.

Ongoing Clinical Trials on Citric Acid Monohydrate

  • Study on the Effects of Custodiol and Buckberg Cardioplegia in Patients Undergoing Major Heart Surgery with Prolonged Aortic Clamping

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Cardioplegia: A medical technique used in cardiac surgery to temporarily stop the heart by injecting a special solution (cardioplegia solution) into it. This allows surgeons to operate on a still, bloodless heart.
  • Extracorporeal circulation: A technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
  • Aortic clamping: A surgical technique where the aorta (the main artery from the heart) is temporarily clamped to stop blood flow, allowing surgeons to operate on the heart.
  • Troponin: A protein released into the blood when the heart muscle has been damaged, such as during a heart attack. Measuring troponin levels helps doctors diagnose heart muscle injury.
  • Perioperative: The time period surrounding a surgery, including before, during, and after the procedure.
  • Ionotropics: Drugs that change the force of the heart's contractions. They are often used to support heart function after surgery.
  • AKIN-III acute kidney failure: A severe stage of sudden kidney damage or failure, classified according to the Acute Kidney Injury Network (AKIN) criteria.
  • AMI: Acute Myocardial Infarction, commonly known as a heart attack. It occurs when blood flow to part of the heart is blocked, causing damage to the heart muscle.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-custodiol-and-buckberg-cardioplegia-in-patients-undergoing-major-heart-surgery-with-prolonged-aortic-clamping/