Study Comparing Sodium Chloride and Lactated Ringer’s Solution for Patients with Acute Pancreatitis

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What is this study about?

This clinical trial is focused on studying the treatment of acute pancreatitis, a condition where the pancreas becomes inflamed suddenly. The trial compares two different solutions used for resuscitation, which is the process of restoring someone to life or consciousness. The first solution is called normal saline, which is a saltwater solution. The second solution is lactated Ringer’s solution, which contains a mix of sodium lactate, potassium chloride, sodium chloride, and calcium chloride dihydrate. These solutions are given to patients through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein.

The purpose of the study is to investigate how these two solutions affect the severity and safety of acute pancreatitis. The trial will look at how often patients experience moderately severe to severe forms of the condition. It will also monitor for any safety concerns, such as fluid overload, which is when the body has too much fluid, or issues like kidney injury, high levels of potassium or calcium in the blood, and acidosis, which is when there is too much acid in the body.

Participants in the study will receive one of the two solutions and will be monitored for 30 days to see how their condition progresses. The study will also track any complications, the need for additional treatments, and the overall recovery process, including how quickly patients can start eating normally again. The trial aims to provide valuable information on which solution might be more effective and safer for treating acute pancreatitis.

1 joining the trial

Upon joining the trial, you will be asked to provide your consent by signing an informed consent form. This confirms your understanding and agreement to participate in the study.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes verifying that you are 18 years or older and have been diagnosed with acute pancreatitis based on specific criteria such as abdominal pain, elevated enzyme levels, or imaging results.

3 randomization

You will be randomly assigned to receive either normal saline or lactated Ringer’s solution. This process ensures that each participant has an equal chance of receiving either treatment.

4 treatment administration

The assigned solution will be administered to you through an intravenous infusion. This means the solution will be delivered directly into your bloodstream through a vein. The frequency and duration of the infusion will be determined by the medical team based on your specific needs.

5 monitoring and follow-up

Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess the severity of your condition and any potential side effects. The main focus will be on the occurrence of moderately severe to severe acute pancreatitis and any safety concerns such as fluid overload or kidney issues.

6 completion of trial

The trial will conclude within 30 days after your randomization. At this point, a final assessment will be conducted to evaluate the outcomes of the treatment you received.

Who Can Join the Study?

  • Patient is 18 years or older.
  • Has a diagnosis of acute pancreatitis. This means the patient must meet at least two of the following three criteria:
    • Experiencing typical abdominal pain.
    • Having an increase in serum amylase or lipase levels that is more than three times the normal limit. These are enzymes that help digest food, and high levels can indicate pancreatitis.
    • Showing signs of acute pancreatitis in imaging, such as a CT scan or MRI.
  • Has signed an informed consent. This means the patient understands the study and agrees to participate.

Who Cannot Join the Study?

  • Patients with acute pancreatitis cannot participate. Acute pancreatitis is a sudden inflammation of the pancreas, an organ that helps with digestion and blood sugar regulation.
  • Patients who are under 18 years old or over 65 years old are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with a history of kidney problems are excluded. This includes any issues with kidney function or previous kidney disease.
  • Patients with heart failure cannot participate. Heart failure is a condition where the heart does not pump blood as well as it should.
  • Patients with liver disease are not eligible. Liver disease refers to any condition that affects the liver’s ability to function properly.
  • Patients with electrolyte imbalances are excluded. Electrolyte imbalances occur when the levels of minerals in the blood, like potassium or calcium, are too high or too low.
  • Patients who have had a recent surgery or are planning to have surgery soon cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Del Mar Barcelona Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Consorci Sanitari De Terrassa Terrassa Spain
Virgen del Rocío University Hospital Sevilla Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hospital Universitario Lucus Augusti Lugo Spain
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA Valencia Spain
Hospital Costa del Sol Marbella Spain
Hefdjgxi Uiftthuprnlhe Dy Lb Psvdobut Madrid Spain
Hjajawkj Uuhxmszisueaf Mqyaupx Dl Vninsbmuqs Santander Spain
Ppea Tufcz Hupubizu Ucyysrhyqifx Sabadell Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
19.06.2023
Spain Spain
Not recruiting
19.06.2023

Trial locations

Normal Saline is a solution that contains water and a small amount of salt. It is often used in medical settings to provide fluids to patients who need them. In this trial, normal saline is being used to help treat people with acute pancreatitis, a condition where the pancreas becomes inflamed. The goal is to see how well normal saline works in reducing the severity of this condition and to ensure it is safe for patients.

Lactated Ringer’s Solution is a fluid that contains water, a small amount of salt, and other important minerals like potassium and calcium. It is used to provide hydration and restore the balance of fluids and minerals in the body. In this trial, lactated Ringer’s solution is being tested to see if it is more effective or safer than normal saline in treating acute pancreatitis. The researchers want to find out if it can help reduce the severity of the condition and avoid any potential side effects.

Investigated diseases:

Acute pancreatitis – Acute pancreatitis is a sudden inflammation of the pancreas. It occurs when digestive enzymes become activated while still in the pancreas, causing irritation and inflammation of pancreatic tissue. The disease can progress from mild discomfort to severe, life-threatening conditions. In its progression, acute pancreatitis can lead to complications such as necrotizing pancreatitis, where parts of the pancreas die, and systemic inflammatory response syndrome (SIRS). It may also result in organ failure, including respiratory or kidney failure. The condition often requires hospitalization for monitoring and supportive care.

Trial ID:
2023-509879-16-00
Protocol code:
WATERLAND
NCT ID:
NCT05781243
Trial Phase:
Therapeutic confirmatory (Phase III)

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