Saline vs. Ringer's: which fluid saves more lives in septic shock?

NCT ID NCT03677102

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large trial tested whether a lower-chloride fluid (Ringer's Lactate) reduces death and kidney injury compared to standard saline in 1,113 adults with septic shock. Participants received either fluid within 6 hours of hospital arrival. The study aims to settle a long-standing debate and guide 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
Intravenous fluids (normal saline vs. Ringer's Lactate)
What this could lead to
If one fluid is better, it could become the standard for treating septic shock, potentially saving thousands of lives each year.
What could go wrong
This trial is already completed, but results may not show a clear winner. Even if one fluid is better, it won't cure sepsis—just improve management.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

1,113 people

The number who actually took part.

Started

Sep 2018

Finished

Feb 2026

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

16 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: * patients 16 years or greater who meet all of the following: * require fluid resuscitation for refractory hypotension (systolic blood pressure \<90 mmHg or mean arterial blood pressure\<65 mmHg after 1 Litre bolus over 1 hour or less or organ hypo-perfusion (serum lactate \>4 mmol/L) * have a clinical suspicion of infection * are within 6 hours of hospital admission or critical care response team consultation * are anticipated to require ICU admission Exclusion Criteria: * intracranial bleed or intracranial hypertension during the index hospital admission * 10% of body surface area acute burn injury * bleeding/hemorrhage as likely cause of hypotension * a lack of commitment to life support * have previously enrolled in FISSH, or a confounding trial (e.g. a trial examining the effect of other intravenous fluids in septic shock patients) * been transferred from another hospital or facility \>6 hours since presentation to first hospital * pre-established end stage renal disease (ESRD) or are receiving hemodialysis (intermittent or continuous) at time of enrolment, or * been admitted to ICU directly from the operating room or post anaesthetic care unit

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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

  • Brantford General Hospital

    Brantford, Ontario, N3R 1G9, Canada

  • CHU de Québec Université Laval

    Québec, Quebec, G1J 1Z4, Canada

  • Cape Breton Regional Hospital

    Sydney, Nova Scotia, Canada

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, Canada

  • Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal

    Montreal, Quebec, H4J 1C5, Canada

  • Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)

    Trois-Rivières, Quebec, Canada

  • Grey Nuns Community Hospital

    Edmonton, Alberta, Canada

  • Halifax Infirmary

    Halifax, Nova Scotia, Canada

  • Hamilton General Hospital

    Hamilton, Ontario, Canada

  • Juravinski Hospital-Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C1, Canada

  • King Abdulaziz Medical City- Riyadh (KAMC-R)

    Riyadh, Saudi Arabia

  • King Faisal Specialist Hospital & Research Centre

    Riyadh, Saudi Arabia

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9, Canada

  • Lakeridge Health - Ajax Pickering

    Ajax, Ontario, Canada

  • London Health Sciences - University Hospital

    London, Ontario, Canada

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A 5W9, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Niagara Health, St Catharines Site

    St. Catharines, Ontario, L2S 0A9, Canada

  • Royal University Hospital

    Saskatoon, Saskatchewan, Canada

  • St Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6, Canada

  • St Paul's Hospital

    Saskatoon, Saskatchewan, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • Unity Health (St. Michael's Hospital)

    Toronto, Ontario, M5B 1W8, Canada

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, Canada

  • University of Calgary - Rockyview General Hospital

    Calgary, Alberta, Canada

  • Victoria General

    Halifax, Nova Scotia, Canada

  • Windsor Regional Hospital - Ouellette Campus

    Windsor, Ontario, Canada

  • Windsor Regional Hospital -Metropolitan Campus

    Windsor, Ontario, Canada

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