Fluids in Septic Shock (FISSH)

NCT03677102 | Completed Phase 2

• 1 other identifier: 1515
• Study Type: interventional
• Target: 1,113
• Locations: 2 countries
• Sites: 30

Brief 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.

Conditions

Sepsis, Septic Shock

Outcome Measures

Primary Outcomes (1)

• 30 day mortality

  Investigators expect that if a difference in survival is demonstrated that this will be evident within 30 days.

  up to 30 days

Secondary Outcomes (13)

• Hospital mortality

  up to 30 days

• ICU mortality

  up to 30 days

• Hospital length of stay

  up to 30 days

• ICU length of stay

  up to 30 days

• Acute Kidney Injury

  up to 30 days

Study Arms (2)

higher chloride solutions

ACTIVE COMPARATOR

higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)

Other: higher chloride crystalloid

lower chloride solutions

ACTIVE COMPARATOR

lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)

Other: lower chloride crystalloid

Interventions

higher chloride crystalloid OTHER

Normal saline (chloride concentration 154 mmol/L)

higher chloride solutions

lower chloride crystalloid OTHER

Ringer's Lactate (chloride concentration 110 mmol/L)

lower chloride solutions

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• intracranial bleed or intracranial hypertension during the index hospital admission
• % 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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (30)

University of Calgary - Foothills Medical Centre

Calgary, Alberta, Canada

Location

University of Calgary - Rockyview General Hospital

Calgary, Alberta, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Location

Halifax Infirmary

Halifax, Nova Scotia, Canada

Location

Victoria General

Halifax, Nova Scotia, Canada

Location

Cape Breton Regional Hospital

Sydney, Nova Scotia, Canada

Location

Lakeridge Health - Ajax Pickering

Ajax, Ontario, Canada

Location

Brantford General Hospital

Brantford, Ontario, N3R 1G9, Canada

Location

St Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital-Hamilton Health Sciences

Hamilton, Ontario, L8V 1C1, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

London Health Sciences - University Hospital

London, Ontario, Canada

Location

Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

Location

Niagara Health, St Catharines Site

St. Catharines, Ontario, L2S 0A9, Canada

Location

Unity Health (St. Michael's Hospital)

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Windsor Regional Hospital - Ouellette Campus

Windsor, Ontario, Canada

Location

Windsor Regional Hospital -Metropolitan Campus

Windsor, Ontario, Canada

Location

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

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

CHU de Québec Université Laval

Québec, Quebec, G1J 1Z4, Canada

Location

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

Sherbrooke, Quebec, J1H 5N4, Canada

Location

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

Trois-Rivières, Quebec, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

St Paul's Hospital

Saskatoon, Saskatchewan, Canada

Location

King Abdulaziz Medical City- Riyadh (KAMC-R)

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Bram Rochwerg, MSc,MD,FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 19, 2018
• Study Start: September 9, 2018
• Primary Completion: February 2, 2026
• Study Completion: February 10, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

SA (2); CA (28)