AuthorisedTherapeutic use (Phase IV)Interventional

Normal saline versus lactated Ringer’s solution for fluid administration in acute pancreatitis, an open-label multicenter randomized controlled trial: the WATERLAND trial

The WATERLAND study is investigating the best fluid to give people who have acute pancreatitis, which is a sudden inflammation of the pancreas. Researchers want to find out if one common fluid, called Ringer's lactate solution, is better than another, called normal saline, at preventing serious complications. They will be watching to see if one fluid leads to fewer cases of moderately severe or severe pancreatitis. They're also carefully checking for side effects like too much fluid in the body, kidney problems, or changes in blood chemistry. This is a real-world study, happening in different hospitals, to see which fluid works best in everyday care.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

720

Start

17 May 2024

Acute Pancreatitis

What is this study about?

When you have acute pancreatitis, it means your pancreas, an organ that helps with digestion, has suddenly become inflamed. This can be very painful and sometimes quite serious. Doctors often give fluids through a drip, directly into your bloodstream, to help your body recover and stay hydrated.

This study, called WATERLAND, is looking at two common types of fluid that doctors might use: Ringer's lactate solution and normal saline. The main goal is to see if one of these fluids helps people with acute pancreatitis get better faster and avoid more serious problems. The researchers want to know if one fluid choice makes it less likely for your pancreatitis to become moderately severe or severe, according to a standard way of classifying the illness.

It's really important for doctors to know which treatments work best for patients. By comparing these two common fluids in a careful way, the WATERLAND study hopes to provide clear answers that can help improve care for everyone who experiences acute pancreatitis in the future.

Key takeaways

Compares two common fluids for acute pancreatitis.
Aims to find which fluid prevents more severe problems.
Very close monitoring for safety and side effects.
Open to adults aged 18 and over, both men and women.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old, and there is no upper age limit. The study is open to both men and women.

The important thing is that you have been diagnosed with acute pancreatitis. The doctors will check your medical records and current health to make sure the study is a good fit for you and that you meet all the specific health criteria for joining.

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?
Do you have a recent diagnosis of acute pancreatitis?
Are you currently receiving hospital care for your pancreatitis?
Are you able to understand and consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the WATERLAND study, doctors will give you one of the two study fluids through a drip as part of your standard care for acute pancreatitis. You won't know which fluid you're getting, and neither will your doctors, to make sure the results are fair. This is called an 'open-label' study. The study will mainly involve doctors collecting information about your health, how your pancreatitis is progressing, and any side effects you might experience while you are in the hospital.

There will be regular checks, including blood tests, to monitor your condition and ensure your safety. The doctors will be looking for specific problems like fluid overload, kidney issues, or changes in your blood. The total duration of your participation would be for as long as you are receiving hospital care for your acute pancreatitis, and doctors will continue to follow up on your progress during your hospital stay.

Potential risks and benefits

Taking part in this study means you'll be receiving a standard fluid treatment for acute pancreatitis, which your doctors would likely give you anyway. A potential benefit is that the study might show one fluid is better, helping future patients, and your care will be closely monitored. Potential risks are that side effects, like fluid overload or kidney problems, could occur with either fluid, as these can happen with pancreatitis treatment in general. However, the study team will be carefully watching for any issues. Remember, you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary

Common questions

What is acute pancreatitis?

It's a sudden inflammation of your pancreas, an organ that helps digest food. It can cause severe tummy pain.

What kind of treatments are being tested?

The study is comparing two common types of fluid that are given through a drip: Ringer's lactate solution and normal saline.

Will I know which fluid I'm getting?

No, neither you nor your doctors will know which fluid you receive. This helps keep the study fair and unbiased.

What are doctors looking for in this study?

They want to see if one fluid type leads to fewer serious problems from pancreatitis and fewer side effects like kidney issues or fluid build-up.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and your medical care will not be affected.