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ER fluid showdown: which IV fluid saves more sepsis patients?

NCT ID NCT07240701

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether Ringer's lactate or normal saline is better for the first fluids given to adults with sepsis in the emergency department. About 88 participants will receive one of the two fluids and be monitored for 24 hours. The main goal is to see if one fluid reduces deaths within that day.

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

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

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: * Adult male or female patients (≥18 years of age) presenting to the emergency department. * Diagnosed or suspected sepsis secondary to an infectious cause. * Provision of written informed consent by the patient, or if the patient is unable to consent, by a first-degree relative or legally authorized representative. Exclusion Criteria: * Age under 18 years old. * Pregnant women. * Informed consent was not obtained from the patient or their first-degree relative/legal guardian. * Patients who are receiving cardiopulmonary resuscitation (CPR) or who require endotracheal intubation at the time of presentation. * Patients with severe volume depletion unrelated to sepsis (e.g., diabetic ketoacidosis, burns, or active gastrointestinal bleeding). * Patients with severe hyperkalemia (serum potassium level of at least 6.5 mmol/L with ECG changes). * Patients with hypotension that is not related to sepsis (e.g., active hemorrhage or intracranial bleeding). * Patients with clinical signs of pulmonary edema or congestive heart failure. * Cases in which the treating physician determines that one isotonic crystalloid (Ringer's lactate or 0.9% NaCl) is clearly superior to the other due to clinical condition or comorbidities. * Cases in which the treating physician anticipates that fluid therapy might be delayed due to study participation. * Patients requiring immediate hospital or ICU admission before completion of initial emergency department resuscitation. * Patients with sepsis sources requiring urgent invasive intervention known to directly affect mortality (e.g., an undrainable abscess or osteomyelitis). Additional exclusion criteria based on the contraindications listed in the Ringer's lactate product information:, * Known hypersensitivity to sodium lactate. * Extracellular hyperhydration or hypervolemia. * Severe renal failure with oliguria or anuria. * Decompensated heart failure. * Hypercalcemia. * Metabolic alkalosis or severe metabolic acidosis. * Conditions associated with impaired lactate metabolism, such as lactic acidosis, severe liver failure, and cirrhosis with ascites. * Current use of digitalis preparations (e.g., digoxin).

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Kutahya City Hospital

    Kütahya, 43100, Turkey (Türkiye)

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