Comparing high and low chloride fluids for treating septic shock
Fluids in Septic Shock (FISSH): a Randomized Controlled Trial
PHASE2; PHASE3 · McMaster University · NCT03677102
This study tests whether using fluids with high or low chloride levels can improve recovery for patients with septic shock.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1096 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | McMaster University (other) |
| Locations | 23 sites (Calgary, Alberta and 22 other locations) |
| Trial ID | NCT03677102 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of intravenous fluids with different chloride concentrations on patients experiencing septic shock. It aims to compare the outcomes of patients receiving high chloride solutions, such as normal saline, against those receiving low chloride solutions, like Ringer's Lactate. The study focuses on critical patient outcomes, including mortality rates and kidney failure, and is designed to provide direct evidence to inform clinical practice. By building on previous pilot studies, this larger trial seeks to clarify the best fluid resuscitation strategy for septic shock patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 years or older who require fluid resuscitation for septic shock and are suspected of having an infection.
Not a fit: Patients with intracranial bleeding, severe burns, or those not committed to life support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for septic shock, potentially reducing mortality and complications.
How similar studies have performed: Previous studies have suggested potential benefits of low chloride solutions, but this trial aims to provide definitive randomized controlled trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Calgary, Alberta and 22 other locations
- University of Calgary - Foothills Medical Centre — Calgary, Alberta, Canada (RECRUITING)
- University of Calgary - Rockyview General Hospital — Calgary, Alberta, Canada (RECRUITING)
- Grey Nuns Community Hospital — Edmonton, Alberta, Canada (RECRUITING)
- Halifax Infirmary — Halifax, Nova Scotia, Canada (RECRUITING)
- Victoria General — Halifax, Nova Scotia, Canada (RECRUITING)
- Brantford General Hospital — Brantford, Ontario, Canada (RECRUITING)
- St Joseph's Healthcare — Hamilton, Ontario, Canada (RECRUITING)
- Juravinski Hospital-Hamilton Health Sciences — Hamilton, Ontario, Canada (RECRUITING)
- Hamilton General Hospital — Hamilton, Ontario, Canada (RECRUITING)
- Kingston General Hospital — Kingston, Ontario, Canada (RECRUITING)
- London Health Sciences Centre - Victoria Hospital — London, Ontario, Canada (RECRUITING)
- London Health Sciences - University Hospital — London, Ontario, Canada (RECRUITING)
- Lakeridge Health — Oshawa, Ontario, Canada (RECRUITING)
- Niagara Health, St Catharines Site — St Catharines, Ontario, Canada (RECRUITING)
- Unity Health (St. Michael's Hospital) — Toronto, Ontario, Canada (RECRUITING)
- Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
- Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal — Montreal, Quebec, Canada (RECRUITING)
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montréal, Quebec, Canada (RECRUITING)
- Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke — Sherbrooke, Quebec, Canada (RECRUITING)
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) — Trois-Rivières, Quebec, Canada (RECRUITING)
- King Abdulaziz Medical City- Riyadh (KAMC-R) — Riyadh, Saudi Arabia (RECRUITING)
- King Faisal Specialist Hospital & Research Centre — Riyadh, Saudi Arabia (RECRUITING)
Study contacts
- Principal investigator: Bram Rochwerg, MSc,MD,FRCPC — McMaster University
- Study coordinator: Bram Rochwerg, MSc,MD,FRCPC
- Email: rochwerg@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock