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Riboflavin Sodium Phosphate Dihydrate

This article discusses the use of Riboflavin Sodium Phosphate Dihydrate, a component of a multivitamin solution called Cernevit, in clinical trials. The focus is on its potential application in treating patients with cardiogenic shock who are being weaned from extracorporeal membrane oxygenation (ECMO). While the primary drug being studied is Levosimendan, the multivitamin solution containing Riboflavin Sodium Phosphate Dihydrate is used as part of the overall treatment protocol.

Table of Contents

What is Riboflavin Sodium Phosphate Dihydrate?

Riboflavin Sodium Phosphate Dihydrate is a form of vitamin B2, also known as riboflavin. It is an important component in multivitamin preparations. This substance is also referred to as Riboflavin-5-phosphoric acid monosodium dihydrate, which is its synonym.[1]

Medical Uses

Riboflavin Sodium Phosphate Dihydrate is primarily used as part of multivitamin formulations. These formulations are often used to supplement nutrition in patients who may have deficiencies or increased needs for vitamins. In the context of the clinical trial data provided, it is part of a multivitamin preparation called Cernevit, which is used in injectable or infusible form.[1]

Administration

The multivitamin preparation containing Riboflavin Sodium Phosphate Dihydrate is administered as a solution for injection or infusion. This means it can be given directly into a vein (intravenously) or through a drip (infusion). This method of administration is particularly useful for patients who cannot take vitamins orally, such as those who are critically ill or undergoing certain medical procedures.[1]

Other Components in the Multivitamin Preparation

The multivitamin preparation (Cernevit) that contains Riboflavin Sodium Phosphate Dihydrate also includes several other vitamins and nutrients. These include:[1]

  • Retinol Palmitate: A form of Vitamin A
  • Ascorbic Acid: Vitamin C
  • Colecalciferol: Vitamin D3
  • Cyanocobalamin: Vitamin B12
  • Dexpanthenol: A form of Vitamin B5
  • Folic Acid: Vitamin B9
  • Nicotinamide: A form of Vitamin B3
  • Pyridoxine Hydrochloride: Vitamin B6
  • D-Biotin: Vitamin B7
  • DL-Alpha-Tocopherol: A form of Vitamin E
  • Cocarboxylase Tetrahydrate: A form of Vitamin B1

This combination of vitamins is designed to provide comprehensive nutritional support for patients who may have difficulty obtaining or absorbing these nutrients through their regular diet.

Current Clinical Trial

While the provided clinical trial information doesn’t specifically focus on Riboflavin Sodium Phosphate Dihydrate, it’s worth noting that the multivitamin preparation containing this compound is being used in a study related to a different medication. The trial is investigating the effects of a drug called Levosimendan in patients with cardiogenic shock who are being weaned from a life support machine called ECMO (Extracorporeal Membrane Oxygenation).[1]

Key points about this trial include:

  • It’s exploring a new use for an already approved drug (Levosimendan)
  • The study focuses on patients with cardiogenic shock, a condition where the heart suddenly can’t pump enough blood to meet the body’s needs
  • It aims to see if Levosimendan can help improve heart function in these critically ill patients
  • The multivitamin preparation (which includes Riboflavin Sodium Phosphate Dihydrate) is likely being used as part of the standard care for these patients, ensuring they receive necessary nutrients while critically ill

This trial highlights the importance of comprehensive care in critically ill patients, which often includes nutritional support through multivitamin preparations like the one containing Riboflavin Sodium Phosphate Dihydrate.

Aspect Details
Study Drug Levosimendan (primary), Cernevit (containing Riboflavin Sodium Phosphate Dihydrate)
Medical Condition Cardiogenic Shock
Primary Objective Assess efficacy of Levosimendan in improving cardiac output and pulsatile flow during ECMO weaning
Primary Outcome Change in left ventricular outflow tract velocity time integral
Key Inclusion Criteria Age ≥ 18 years, undergoing ECMO for cardiogenic shock or refractory cardiac arrest
Key Exclusion Criteria Coma with fixed pupil dilation, mechanical cause of shock, severe peripheral arterial disease, pregnancy
Secondary Outcomes Changes in pulse pressure, ECMO weaning failure rates, mortality, urinary output, central venous saturation
Cernevit Administration Solution for injection/infusion

FAQ

  • What is the main purpose of the clinical trial involving Riboflavin Sodium Phosphate Dihydrate? The main purpose of the trial is to assess the efficacy of Levosimendan in improving cardiac output and pulsatile flow for patients with cardiogenic shock being weaned from ECMO. Riboflavin Sodium Phosphate Dihydrate is a component of the multivitamin solution Cernevit, which is used as part of the overall treatment protocol.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults aged 18 years or older who are undergoing ECMO for cardiogenic shock or refractory cardiac arrest. However, there are several exclusion criteria, such as severe peripheral arterial disease or pregnancy.
  • What is the primary outcome being measured in this trial? The primary outcome is the change in left ventricular outflow tract velocity time integral, measured by Doppler echocardiography, from baseline to 72 hours after initiation of ECMO or before cessation of ECMO support, whichever occurs first.
  • How is Riboflavin Sodium Phosphate Dihydrate administered in this trial? Riboflavin Sodium Phosphate Dihydrate is a component of Cernevit, which is administered as a solution for injection or infusion. The exact dosage and administration details are not specified in the provided information.
  • What are some of the secondary outcomes being evaluated in this trial? Secondary outcomes include changes in pulse pressure, ECMO weaning failure rates, all-cause mortality at 28 days, urinary output, central venous saturation, and total days requiring ECMO support.

Ongoing Clinical Trials on Riboflavin Sodium Phosphate Dihydrate

  • Study on the Effects of Levosimendan for Patients with Cardiogenic Shock Being Weaned from ECMO

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Cardiogenic Shock: A serious condition where the heart suddenly can't pump enough blood to meet the body's needs, often due to a severe heart attack.
  • ECMO (Extracorporeal Membrane Oxygenation): A life support machine that pumps and oxygenates a patient's blood outside the body, allowing the heart and lungs to rest.
  • Levosimendan: A medication used to treat acute heart failure by improving the heart's ability to pump blood.
  • Doppler Echocardiography: An ultrasound test that uses sound waves to create images of the heart and measure blood flow through the heart and blood vessels.
  • Left Ventricular Outflow Tract Velocity Time Integral: A measurement of blood flow from the left ventricle of the heart, used to assess cardiac function.
  • Pulse Pressure: The difference between systolic and diastolic blood pressure, which can indicate how well the heart is functioning.
  • Central Venous Saturation: A measure of how much oxygen is in the blood returning to the heart, used to assess the balance between oxygen delivery and consumption in the body.
  • Riboflavin Sodium Phosphate Dihydrate: A form of vitamin B2 used in multivitamin preparations, important for energy metabolism in the body.
  • Cernevit: A multivitamin preparation containing various vitamins, including Riboflavin Sodium Phosphate Dihydrate, used for intravenous nutrition.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-levosimendan-for-patients-with-cardiogenic-shock-being-weaned-from-ecmo/