CompletedInterventional

A clinical trial comparing how well two solutions protect the heart during heart surgery in children

Some children born with heart defects need surgery to repair them. During these operations, surgeons use a heart-lung machine to keep blood flowing around the body, while a special fluid temporarily stops the heart so it can be safely operated on. This protective fluid is called a cardioplegia solution. Currently, UK hospitals usually use a fluid called St. Thomas', while hospitals in the United States commonly use one called del Nido. Both liquids are already widely used and have been given safely to thousands of children worldwide. The DESTINY trial compares these two fluids directly to see if one protects young hearts better, reduces complications, and helps children heal more quickly. Taking part does not change the operation itself or add any extra visits. It simply decides which of these two proven fluids the surgeon will use during the planned procedure.

At a glance

Status

Completed

Sponsor

University of Birmingham

Enrolment target

220

Start

07 Feb 2022

Estimated completion

13 Mar 2025

Cardiac surgery

What is this study about?

When a child is born with a heart condition, they may need an operation to repair the defect. These are delicate operations that require the heart to be completely still so the surgeon can work with great precision. To do this safely, a heart-lung machine takes over the work of pumping blood and oxygen around the body, allowing doctors to pause the heart for a short time.

To protect the heart while it is stopped, doctors gently flush it with a cool, specialised liquid called a cardioplegia solution. This fluid protects the heart muscle cells from strain and damage while they are resting. In the UK, the standard liquid used is called St. Thomas' solution. In the US, surgeons more often use a different liquid called del Nido solution.

Both of these liquids are well-established and trusted by doctors around the world. However, some early research suggests that the del Nido fluid might offer better protection and allow for a smoother recovery. The DESTINY trial has been designed to settle this question. By carefully comparing both fluids across UK hospitals, researchers hope to discover which one gives children the best possible recovery with the fewest complications after surgery.

Key takeaways

The study compares two widely used fluids that protect the heart during children's heart surgery.
Both fluids are already proven, safe, and used in thousands of operations globally.
Participation does not require extra hospital visits, blood tests, or painful procedures.
The trial aims to find out which fluid helps young patients recover faster with fewer complications.
Joining is completely voluntary, and you can withdraw at any time without affecting your child's treatment.

Who may be eligible?

This trial is open to babies and children under 16 years of age who are already scheduled for planned heart surgery using a heart-lung machine. The surgical team must expect the heart to be paused for at least 30 minutes during the operation, and the child must weigh 50 kilograms (about 7 stone 12 pounds) or less at the time of screening.

Children cannot take part if they need emergency surgery or if their heart only needs to be paused for a very short time (under 30 minutes). It is also not suitable for children who have had a similar heart operation within the last month, those receiving mechanical heart pump support, or those who have had a heart transplant.

In addition, children with known allergies to any ingredients in the fluids (such as local anaesthetics like lidocaine or procaine) or those with certain blood conditions affected by cold temperatures cannot join. A parent or legal guardian must give full permission for their child to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My child is under 16 years of age.
My child weighs 50 kg (approx. 7 stone 12 lbs) or less.
My child is booked for a planned, non-emergency heart surgery.
The surgeon expects the heart to be stopped for 30 minutes or more.
My child does not have known allergies to local anaesthetics like lidocaine.
My child has not had heart surgery where the heart was stopped within the last 30 days.

Answer every question to see your result.

What does participation involve?

Taking part in the study takes place entirely during your child's scheduled operation, so it will not require any extra hospital visits, extra blood tests, or longer stays in hospital.

Before the operation, a computer will randomly choose which fluid your child receives—either del Nido or St. Thomas'. This is done by chance, like flipping a coin, to keep the comparison fair. The surgeon will then use that fluid to protect your child's heart during the repair.

After the operation, the medical team will monitor your child's recovery as normal while they are on the ward and in intensive care. Researchers will collect routine medical details from your child's hospital notes, such as how long they needed breathing support and how quickly they recovered. There are no additional appointments once your child is discharged from hospital.

Potential risks and benefits

Taking part may not help your child directly, but the findings could help doctors improve care and recovery times for thousands of children having heart surgery in the future. Both fluids are already widely used across the world and have strong safety records. Being in the study will not cause your child any additional pain, distress, or medical procedures beyond their planned surgery. Any heart surgery carries risks, which your surgical team will explain in detail, but taking part in this trial does not add extra surgical risk. Joining is completely voluntary, and you are free to withdraw your consent at any time without your child's NHS care being affected in any way.

Locations (4)

Birmingham Children’s Hospital
Approximate
Birmingham, England
Bristol Royal Hospital for Children
Approximate
Bristol, England
Great Ormond Street Hospital
Approximate
London, England
Leeds General Infirmary (Children's Hospital)
City only
Leeds, England

Common questions

Will taking part make my child's surgery longer or more dangerous?

No. The operation is carried out in the standard way. The only difference is which of the two protective fluids the surgeon uses while the heart is resting.

Are these fluids new or experimental?

No. Both St. Thomas' and del Nido fluids have been used routinely for many years in thousands of children's heart operations worldwide.

Will my child need extra tests or needles?

No. The trial does not require any extra blood tests, scans, or clinic appointments. The researchers only use information collected during your child's normal care.

Can I choose which fluid my child receives?

No. A computer randomly decides which solution is used to ensure the study remains fair and scientifically accurate.

What happens if I change my mind?

You can change your mind and withdraw at any time before the operation. Your decision will not alter your relationship with the hospital or the standard of care your child receives.

How to find out more

Nigel Drury

nigel.drury@nhs.net +44 (0)121 3338731 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.