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Trometamol

Clinical trials investigating Trometamol are studying different hospital settings, including major cardiac surgery and brain-dead organ donors. These studies aim to compare treatment approaches, measure safety and effectiveness, and see how well patients or donors tolerate the study care. The target groups are adults undergoing heart surgery and brain-dead organ donors.

Table of Contents

Trial overview

The available trial data for Trometamol includes two authorised interventional studies in hospital settings.[1][2] One study is in major cardiac surgery, and the other is in brain-dead organ donors.[1][2]

Cardiac surgery study

The first study is the CARDIO-HEART clinical trial, which evaluates the clinical impact of the type of cardioplegia used during major cardiac surgery with extracorporeal circulation.[1] The trial compares Custodiol crystalloid cardioplegia with Buckberg blood cardioplegia and aims to show that Custodiol is not worse than Buckberg in this setting.[1]

This study is in Phase 3 and plans to include 600 patients.[1] It is designed for patients having major heart surgery with prolonged aortic clamping times, which means the aorta is closed for a longer period during the operation.[1]

Organ donor study

The second study looks at the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors.[2] The brief summary says the goal is to assess the effect of potassium canrenoate versus placebo on circulation in brain-dead subjects who are candidates for kidney or multiple organ harvesting, including the kidney.[2]

This study is in Phase 2 and plans to include 36 participants.[2] The intervention and comparison are given by vein, and the study is focused on how well the donor’s circulation stays stable before organ removal.[2]

Key outcomes being measured

In the cardiac surgery study, the main outcome is a combined measure of death, perioperative acute heart attack, low heart output needing inotropic drugs, and severe acute kidney failure at 90 days after the intervention.[1] A combined measure means several important events are grouped together into one result.[1]

In the organ donor study, the main outcome is a hierarchical composite of events.[2] This includes cardiac arrest before organ removal, inability to perform the renal swab, the average hourly dose of noradrenaline or adrenaline, and the average hourly amount of crystalloids or colloids used between randomisation and departure to the operating room.[2]

Who can participate

The cardiac surgery trial is for patients undergoing major cardiac surgery with extracorporeal circulation and prolonged aortic clamping times.[1] The donor trial is for brain-dead organ donors who are candidates for kidney or multiple organ harvesting.[2]

These are highly specific groups, so the studies are not for general use in the community.[1][2] They are designed for patients or donors already in a surgical or intensive care setting.[1][2]

Trial phases and status

Both studies are listed as Authorised, which means they have been approved to start.[1][2] The cardiac surgery study is Phase 3, while the donor study is Phase 2.[1][2]

Phase 3 studies usually compare treatments in a larger group and look closely at clinical results.[1] Phase 2 studies usually focus on early testing of how a treatment performs in a smaller group and whether it is tolerated well.[2]

The two studies together show that Trometamol-related trial data is being used in different urgent care settings, with different goals and patient groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-511948-42-00 Phase 3 Cardiovascular surgery Authorised 600
NCT04714710 Phase 2 Brain-dead Organ Donors Authorised 36

FAQ

  • What clinical trials are investigating Trometamol? The trial data includes studies in major cardiac surgery and in brain-dead organ donors. These trials are testing treatment strategies used during hospital care, not long-term outpatient treatment.
  • Who can take part in these trials? One trial includes patients undergoing major cardiac surgery with extracorporeal circulation. Another trial includes brain-dead organ donors who are candidates for kidney or multiple organ harvesting.
  • What phases are these Trometamol trials? The cardiac surgery study is Phase 3. The donor study is Phase 2. These phases show that the studies are testing the treatments in real patient groups and measuring clinical outcomes.
  • What are the trials trying to find out? The cardiac surgery trial is checking whether one cardioplegia approach is not worse than another. The donor trial is checking hemodynamic tolerance, which means how well the body’s circulation stays stable after treatment.
  • What outcomes are being measured? The cardiac surgery trial measures death, perioperative heart attack, low heart output needing drugs, and severe acute kidney failure. The donor trial measures cardiac arrest before organ removal, ability to perform the renal swab, and the amount of blood pressure medicines and fluids needed.

Ongoing Clinical Trials on Trometamol

  • 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

  • Clinical trial: A research study in people that tests a medical treatment or care plan and measures its results.
  • Interventional study: A study where researchers assign a treatment or care approach and then compare outcomes.
  • Phase 2: An earlier trial phase that looks at how a treatment works and how well it is tolerated in a smaller group.
  • Phase 3: A later trial phase that compares treatments in a larger group to see which works better or is not worse.
  • Cardioplegia: A method used during heart surgery to stop the heart safely for the operation.
  • Extracorporeal circulation: A machine that takes over the work of the heart and lungs during surgery.
  • Aortic clamping: A surgical step where the aorta is temporarily closed off to allow heart surgery.
  • Hemodynamic tolerance: How well the body keeps stable blood flow and blood pressure after a treatment.
  • Noradrenaline / adrenaline: Medicines used to support blood pressure and circulation when they are too low.
  • Crystalloids and colloids: Types of fluids given into a vein to support circulation and body fluid balance.
  • Perioperative: The time before, during, and shortly after an operation.
  • AKIN-III acute kidney failure: A severe form of sudden kidney failure measured by a standard grading system.

References