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Study on Normal Saline and Lactated Ringer’s Solution for Adults 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

The study focuses on investigating better management of acute pancreatitis, a condition where the pancreas becomes inflamed suddenly. This study compares two types of fluid therapy: Normal saline (a solution of sodium chloride in water) and Lactated Ringer's solution (a mix containing sodium chloride, potassium chloride, calcium chloride, and sodium lactate in water). These are solutions given through a vein to treat dehydration and loss of fluids caused by acute pancreatitis.

The purpose of the study is to determine which of these fluid therapies results in better outcomes for patients with acute pancreatitis. Patients will receive one of these solutions as part of their treatment to see if it can help improve their condition or prevent it from becoming more severe. This study takes place in multiple hospitals, allowing researchers to gather data from various locations.

By understanding which fluid therapy works best, this study aims to influence treatment methods for patients with acute pancreatitis, improving care for those experiencing this condition. If a particular fluid solution shows better results, it could change routine practices used in treating this common disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must be at least 18 years old and have a diagnosis of acute pancreatitis. This diagnosis is based on at least two of the following criteria: typical abdominal pain, increased levels of specific enzymes in the blood, or signs of pancreatitis in imaging tests.

    The patient must provide informed consent to participate in the study.

  2. Step 2

    Randomization and treatment allocation

    The patient will be randomly assigned to receive one of two types of fluid therapy: normal saline or lactated Ringer's solution. Both are solutions for infusion used to manage fluid levels in the body.

  3. Step 3

    Treatment administration

    The assigned fluid therapy will be administered through an infusion. The specific dosage and frequency will be determined by the medical team based on the patient's condition and response to treatment.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, the patient's condition will be closely monitored. This includes checking for any signs of fluid overload, kidney issues, or imbalances in blood minerals such as potassium and calcium.

    The primary goal is to assess whether the treatment helps in managing the severity of acute pancreatitis.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by May 1, 2025. The patient's participation will end once the treatment period is completed and all necessary assessments have been conducted.

Who can join the trial?

5 criteria

  • Must be at least 18 years old.
  • Must have a diagnosis of acute pancreatitis. This means the patient needs to 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 upper limit. These are substances in the blood that help diagnose pancreatitis.
    • Showing signs of acute pancreatitis in imaging, which means that tests like an ultrasound or CT scan show evidence of the condition.
    • Must sign an informed consent, which is a document that explains the study and confirms the patient's agreement to participate.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing Acute Pancreatitis cannot participate. Acute Pancreatitis is a sudden inflammation of the pancreas, an organ that helps with digestion and blood sugar regulation.
  • Individuals who are younger than 18 years old or older than 65 years old are not eligible to join the study.
  • Both males and females can participate, but those who do not identify as either are excluded.
  • People who are considered part of a vulnerable population, such as those who cannot make decisions for themselves, are not allowed to participate.
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Investigated drugs

  • Normal Saline

    is a fluid solution commonly used in hospitals for hydration and to maintain fluid balance in the body. In this trial, it is being tested to see how effective it is in managing acute pancreatitis by providing necessary fluids to the patient.

  • Lactated Ringer's Solution

    is another type of fluid solution used in medical settings. It contains a mix of sodium chloride, sodium lactate, potassium chloride, and calcium chloride. This solution is being compared to normal saline in the trial to determine which is more effective in treating patients with acute pancreatitis by helping to restore fluid balance and improve patient outcomes.

What is already known about the treatment

  • Normal Saline

    Normal saline is administered intravenously and is commonly used in hospitals for fluid replacement. It is widely recognized in medical literature as a standard treatment for various conditions requiring fluid resuscitation. In the context of acute pancreatitis, it is used to manage fluid levels in the body. Its mechanism of action involves restoring fluid balance and maintaining adequate blood pressure. It is classified as a crystalloid solution.

  • Lactated Ringer's Solution

    Lactated Ringer's solution is also administered intravenously and is used for fluid replacement in medical settings. It is well-documented in medical literature as an effective treatment for conditions needing electrolyte replenishment and fluid resuscitation. For acute pancreatitis, it helps in maintaining fluid and electrolyte balance. Its mechanism of action includes providing electrolytes and lactate, which the liver converts to bicarbonate, aiding in pH balance. It is classified as a balanced crystalloid solution.

Investigated diseases

Acute Pancreatitis – Acute pancreatitis is a sudden inflammation of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. This condition can cause severe abdominal pain, nausea, and vomiting. It often occurs when digestive enzymes become activated while still in the pancreas, leading to irritation and inflammation. The disease can progress from mild discomfort to more severe forms, potentially affecting other organs. In some cases, it may lead to complications such as fluid accumulation or infection. The severity of the condition can vary, and it may require hospitalization for monitoring and supportive care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511229-79-00Estimated enrolment720 patientsSponsorSemmelweis University

sourced from the EU Clinical Trials Register and site verification

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