Fluids in Septic Shock (FISSH)

Last updated: May 5, 2025
Sponsor: McMaster University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Low Blood Pressure (Hypotension)

Treatment

higher chloride crystalloid

lower chloride crystalloid

Clinical Study ID

NCT03677102
1515
  • Ages > 16
  • All Genders

Study Summary

Despite evidence of the physiologic benefits and possible lower mortality associated with low chloride solutions, normal saline remains the most wildly used fluid in the world. Given uncertainty about the impact of lower chloride versus higher chloride solutions on mortality, it is unlikely that clinical practice will change without new and direct randomized controlled trial (RCT) evidence. Editorials published in leading critical care journals have called for RCT's to address this important clinical question. This trial will directly compare low chloride versus normal chloride for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients 16 years or greater who meet all of the following:

  • require fluid resuscitation for refractory hypotension (systolic blood pressure <90mmHg or mean arterial blood pressure<65 mmHg after 1 Litre bolus over 1 hour or lessor 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

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 examiningthe effect of other intravenous fluids in septic shock patients)

  • been transferred from another hospital or facility >6 hours since presentation tofirst 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

Study Design

Total Participants: 1096
Treatment Group(s): 2
Primary Treatment: higher chloride crystalloid
Phase: 2/3
Study Start date:
September 09, 2018
Estimated Completion Date:
March 31, 2026

Study Description

Severe infection can lead to many complications within the human body including low blood pressure, which is called septic shock. The main treatments for septic shock are intravenous antibiotics and intravenous fluid.

There are many different intravenous fluids available for doctors to use. Each one of these fluids has potential advantages as well as potential disadvantages. Doctors will often look at many things when deciding which fluid to give including the results of bloodwork and the clinical characteristics of the patients themselves. There is limited direction from research studies that using one fluid type is better than another. Some preliminary research in the field has suggested that one specific electrolyte, call chloride, may be harmful when given to patients in high concentrations. Animal research has shown that the administration of high chloride fluids may be harmful to the lungs, kidneys, gastrointestinal and muscle cells. Some intravenous fluids have higher concentrations of chloride than others.

The investigators plan to study the impact of giving patients with severe infection intravenous fluids with either a high chloride concentration (normal saline or high chloride albumin) or a low chloride concentration (Ringers Lactate or low chloride albumin). This trial will build on the earlier pilot, phase 1 study and will look at patient-important outcomes such as rate of death, kidney failure and length of stay in the ICU. This larger study has the potential to guide the care of critically ill patients with infection worldwide.

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta
    Canada

    Active - Recruiting

  • Rockyview General Hospital

    Calgary, Alberta
    Canada

    Active - Recruiting

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta
    Canada

    Active - Recruiting

  • University of Calgary - Rockyview General Hospital

    Calgary, Alberta
    Canada

    Active - Recruiting

  • Covenant Health

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Covenant Health-Grey Nuns Community Hospital

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Grey Nuns Community Hospital

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Halifax Infirmary

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • Victoria General

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • Brantford General Hospital

    Brantford, Ontario N3R 1G9
    Canada

    Active - Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Juravinski Hospital-Hamilton Health Sciences

    Hamilton, Ontario L8V 1C1
    Canada

    Active - Recruiting

  • St Joseph's Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • London Health Sciences - University Hospital

    London, Ontario
    Canada

    Active - Recruiting

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Lakeridge Health

    Oshawa, Ontario L1G 2B9
    Canada

    Active - Recruiting

  • Niagara Health, St Catharines Site

    St Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Sunnybrook Helath Sciences Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Unity Health (St. Michael's Hospital)

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

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

    Montreal, Quebec H4J 1C5
    Canada

    Active - Recruiting

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

    Montréal, Quebec
    Canada

    Active - Recruiting

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

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

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

    Trois-Rivières, Quebec
    Canada

    Active - Recruiting

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

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • King Faisal Specialist Hospital & Research Centre

    Riyadh,
    Saudi Arabia

    Active - Recruiting

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