RecruitingNAINTERVENTIONAL

Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery

This study is exploring better ways to perform heart bypass surgery for larger individuals. When undergoing this type of surgery, a heart-lung machine is used, and a blood-thinning medicine called Heparin is given. Currently, the amount of this medicine and the machine's settings are usually based on a person's total weight. However, this might not be ideal for those who are overweight. Researchers want to see if it's safer and works better to base these decisions on 'lean body mass' – essentially, your weight without the fat. The goal is to ensure you get the right amount of medication and the heart-lung machine works optimally, making the surgery as safe and effective as possible for you.

At a glance

Status

Recruiting

Phase

Sponsor

Laval University

Enrolment target

410

Start

21 Aug 2015

Estimated completion

31 Dec 2027

Cardiopulmonary Bypass Obesity

What is this study about?

When someone needs heart surgery, doctors sometimes use a special machine called a heart-lung bypass machine. This machine temporarily takes over the job of your heart and lungs, allowing surgeons to operate on your heart without it beating. During this time, a blood-thinning medication called Heparin is given to prevent blood clots. For people who are overweight, figuring out the exact right amount of Heparin and how fast the bypass machine should pump blood can be tricky. Currently, these decisions are often based on your total body weight.

This study aims to find out if using a different measurement, called 'lean body mass,' might be better. Lean body mass is essentially your body weight minus the weight of your body fat. The idea is that this might give doctors a more accurate way to calculate medication doses and machine settings, leading to better and safer outcomes for overweight patients having heart surgery.

By taking part, you would be helping doctors understand how to fine-tune heart bypass surgery for overweight individuals. This research could lead to improved care for many patients in the future, making their heart bypass operations even safer and more effective. It's all about finding the best and most personalised approach for you.

Key takeaways

The study explores better ways to manage heart bypass surgery for overweight patients.
It's testing if using 'lean body mass' is better than total weight for medication and machine settings.
Participation involves close monitoring during and after your heart surgery.
The goal is to improve safety and effectiveness of surgery for future patients.
You can withdraw from the study at any point without impacting your care.

Who may be eligible?

This study is looking for adults aged 18 or older who are preparing to have heart surgery and are considered overweight (have a Body Mass Index, or BMI, of 30 or more).

However, there are certain reasons why you might not be able to join. For example, if you already have a pacemaker, have had a stroke, or have certain blood conditions or allergies to medications used during surgery, you wouldn't be able to participate. You also can't join if you're pregnant, breastfeeding, or planning to become pregnant, or if you've recently taken certain blood-thinning medications.

Other reasons that might prevent you from joining include having severe kidney or liver problems, active infections around your heart, or needing emergency surgery within 24 hours. If you've had multiple previous heart surgeries or if doctors plan a very specific type of surgery (like one without the heart-lung machine or with very deep cooling), you wouldn't be eligible. The best way to know if you can take part is to discuss it with your doctor.

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.

Are you 18 years old or older?
Are you having heart surgery soon?
Do you have a Body Mass Index (BMI) of 30 or more (meaning you are considered overweight)?
Are you NOT pregnant or breastfeeding?
Do you NOT have an active infection around your heart?
Have you NOT had a stroke or severe kidney/liver problems previously?

Answer every question to see your result.

What does participation involve?

The detailed description of participation isn't provided in the brief summary. Typically, studies like this would involve careful monitoring during your heart surgery and while you recover in the hospital. This would include regular blood tests to check how your blood-thinning medication is working. Researchers would also closely track your recovery and monitor for any side effects.

Participation usually doesn't involve extra visits or medications beyond what's needed for your surgery and recovery, but the exact duration of monitoring and follow-up would be explained by the study team. You might have some additional data collected from your standard medical care.

It's important to remember that all procedures would be part of your normal surgical care, but handled according to the study's specific plan, which focuses on managing your medication and the heart-lung machine based on your lean body mass.

Potential risks and benefits

The potential benefits of taking part in this study are that it could help improve the safety and effectiveness of heart bypass surgery for overweight patients in the future. You might also receive very close monitoring during and after your surgery. However, there's always a possibility of risks with any medical procedure, and this study involves a new approach to medication and machine settings, which may have unknown effects. There could be risks similar to those of standard heart surgery and blood-thinning medications. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Hopital Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is 'lean body mass'?

Lean body mass is your weight without including body fat. It's often used in medicine for more accurate calculations than total body weight alone.

What is a 'heart-lung bypass machine'?

It's a machine that temporarily takes over the job of your heart and lungs during surgery, allowing doctors to operate on a still heart.

What is Heparin?

Heparin is a common medicine used to thin your blood and prevent clots, especially important during heart bypass surgery.

Will I receive different care than other patients?

Your care will be tailored to the study's specific plan for managing your medication and the bypass machine, which might differ from standard practice for overweight patients, but is designed to be safe and effective.

What happens if I change my mind about participating?

You can decide to stop participating in the study at any time, and this will not affect the quality of your medical care.

How to find out more

Hugo Tremblay, Bachelor

hugo.tremblay@criucpq.ulaval.ca 418-656-8711 Official trial record

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