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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

9 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Normal Saline

    Normal saline is administered intravenously, meaning it is given directly into a vein through a needle. It is a widely used fluid in medicine, often mentioned in medical literature as a standard treatment for various conditions requiring fluid resuscitation. Its main therapeutic indication in this trial is to manage acute pancreatitis, a condition where the pancreas becomes inflamed. At the molecular level, normal saline works by replenishing lost fluids and electrolytes, helping to maintain the body's fluid balance. It is classified pharmacologically as a crystalloid solution, which is a type of fluid used to replace lost body fluids.

  • Lactated Ringer's Solution

    Lactated Ringer's solution is also administered intravenously, similar to normal saline, and is used to provide fluids and electrolytes to the body. In the medical field, it is recognized for its role in fluid resuscitation and is frequently discussed in medical literature. This solution is being tested for its effectiveness in treating acute pancreatitis, where it may help reduce the severity of the condition. On a molecular level, lactated Ringer's solution contains a mix of sodium, potassium, calcium, and lactate, which helps restore the body's electrolyte balance and pH level. It is classified as a balanced crystalloid solution, designed to closely mimic the body's natural fluid composition.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509879-16-00Protocol codeWATERLANDEstimated enrolment100 patientsSponsorHospital General Universitario Dr. Balmis

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