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A simple IV fluid choice could tame pancreatitis severity

NCT ID NCT05781243

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether the type of IV fluid given to people with acute pancreatitis affects how severe the disease becomes. About 800 adults with acute pancreatitis will be randomly assigned to receive either lactated Ringer's solution or normal saline for at least 48 hours. The goal is to see if one fluid reduces the chance of developing moderately severe or severe pancreatitis, which involves complications or organ failure. The results could lead to a simple, inexpensive change in emergency care worldwide.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lactated Ringer's solution compared to normal saline, given as intravenous fluid resuscitation for at least 48 hours
What this could lead to
If lactated Ringer's proves better, it could become the standard IV fluid for acute pancreatitis, reducing severe complications worldwide at low cost.
What could go wrong
Previous studies have shown conflicting results, and this trial is open-label, which may introduce bias. The benefit, if any, may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

812 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is 18 years or older * Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging * Signature of informed consent Exclusion Criteria: * New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction \<50% in the last echocardiography * Decompensated cirrhosis (Child's class B or C) * Hyper or hyponatremia (\<135 or \>145 mEq/L) * Hyperkalemia (\>5 mEq/L) * Hypercalcemia (albumin or protein-corrected calcium \>10.5 mg/dL or 2.62 mmol/L) * Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine ≥1.9 mg/dL or ≥170 mmol/l, B) PaO2/FiO2≤300, C) systolic blood pressure \<90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis * Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º) * Time from pain onset to arrival to emergency room \>24 h * Time from confirmation of pancreatitis to randomization \>8 h * Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications * More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dr. Balmis General University Hospital

    Alicante, Alicante, 03010, Spain

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