Ongoing, recruitingTherapeutic use (Phase IV)Interventional

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

The WATERLAND study is a large research project looking at different types of fluid drips used to treat people who suddenly develop inflammation of the pancreas (acute pancreatitis). Researchers are comparing two common fluids: normal saline and lactated Ringer's solution. They want to find out which fluid treatment is better at preventing the condition from becoming more severe or causing serious problems like organ damage within the first 30 days after a patient starts treatment. This study is trying to confirm the best way to help patients recover and avoid complications, ultimately aiming to improve care for acute pancreatitis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital General Universitario Dr. Balmis

Enrolment target

100

Start

11 Jan 2024

Acute pancreatitis

What is this study about?

This study, called WATERLAND, is looking at how we can best treat people who get a sudden, painful swelling of their pancreas, a condition known as acute pancreatitis. When you have acute pancreatitis, your body needs extra fluid, and doctors give this to you through a drip into your arm. There are two main types of fluid doctors usually use: one called 'normal saline' and another called 'lactated Ringer's solution'.

The main goal of this study is to compare these two fluids. We want to see if one of them is better at stopping acute pancreatitis from becoming very serious or causing health problems. Researchers will be looking to see which fluid helps more patients avoid severe complications within the first month of starting treatment. This is important because preventing severe pancreatitis means less pain, fewer medical procedures, and a quicker recovery for patients.

By comparing these two widely used fluids in a careful way, doctors hope to learn which one is the most effective and safest choice. The results could help doctors all over the world make better decisions about how to treat people with acute pancreatitis, leading to improved care and better health for many patients.

Key takeaways

The WATERLAND study compares two common fluid treatments for acute pancreatitis.
It aims to find out which fluid best prevents serious complications in the first 30 days.
Participants will receive standard fluid treatment, either normal saline or lactated Ringer's solution.
Your medical records will be used to track your progress and recovery.
This study could help improve future treatments for acute pancreatitis patients.

Who may be eligible?

This study is open to adults aged 18 years and older. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to join this study if they meet the other requirements. The most important thing is that you have been diagnosed with acute pancreatitis.

Your doctor will check if you meet all the specific health criteria to make sure this study is right for you and safe for you to participate in.

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?
Have you recently been diagnosed with acute pancreatitis?
Are you receiving intravenous fluid treatment for your pancreatitis?
Are you willing for your medical information to be used for research?
Do you understand you might receive either 'normal saline' or 'lactated Ringer's solution'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the two standard fluid treatments through a drip, either normal saline or lactated Ringer's solution, as part of your usual care for acute pancreatitis. You won't know which fluid you are receiving, and neither will your doctors, but this is a common treatment approach. Your medical team will monitor your health very closely during your hospital stay.

Researchers will collect information from your existing medical records, such as how long you stay in hospital, any complications you might have, and results from your blood tests (like C-reactive protein). They will also look at how quickly you can start eating normally again, if you need any extra care like in an intensive care unit, or if you need any procedures.

There are no extra visits or special tests just for the study; all information will come from your routine medical care. The study will mainly focus on what happens in the first 30 days after your treatment begins, but researchers may also track your hospital stay and other longer-term outcomes. The total duration of your participation will be tied to your hospital stay and recovery following your acute pancreatitis.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, as both treatments are standard care for acute pancreatitis. However, your participation will help doctors understand which treatment works best, which could help future patients. There are no additional risks beyond those usually associated with receiving fluid drips for acute pancreatitis, as both fluids are commonly used. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
France

Common questions

What is acute pancreatitis?

It's a sudden inflammation (swelling) of your pancreas, a gland behind your stomach that helps with digestion and blood sugar control. It can cause severe belly pain.

What are 'normal saline' and 'lactated Ringer's solution'?

These are two types of fluid commonly given through a drip into your vein when you're unwell, especially when you need extra fluids, like with acute pancreatitis.

Why is this study important?

By comparing two common treatments, doctors hope to find out which fluid is better at preventing serious complications, leading to better care for people with acute pancreatitis.

Will I know which fluid I'm getting?

No, neither you nor your doctors will know which fluid you are receiving. This is a common way to conduct studies to ensure fair results.

Do I have to do anything extra if I join?

No, your participation won't involve extra appointments or treatments beyond your usual care for acute pancreatitis. All information will come from your routine medical records.