Fluids in Septic Shock (FISSH)
Sepsis, Septic ShockDespite 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
16 and up
Participation 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
Study Location
University of Calgary - Rockyview General Hospital
University of Calgary - Rockyview General HospitalCalgary, Alberta
Canada
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Cape Breton Regional Hospital
Cape Breton Regional HospitalSydney, Nova Scotia
Canada
Contact Study Team
Cheryl Furey, RN, BScN
Juravinski Hospital-Hamilton Health Sciences
Juravinski Hospital-Hamilton Health SciencesHamilton, Ontario
Canada
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London Health Sciences - University Hospital
London Health Sciences - University HospitalLondon, Ontario
Canada
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Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal
Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de MontréalMontreal, Quebec
Canada
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Royal University Hospital
Royal University HospitalSaskatoon, Saskatchewan
Canada
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Halifax Infirmary
Halifax InfirmaryHalifax, Nova Scotia
Canada
Contact Study Team
Novartis Pharmaceuticals
061 324 11 11Trial Transparency email recommended (Toll free for US & Canada)
[email protected]800-633-1610
Brantford General Hospital
Brantford General HospitalBrantford, Ontario
Canada
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Kingston General Hospital
Kingston General HospitalKingston, Ontario
Canada
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Niagara Health, St Catharines Site
Niagara Health, St Catharines SiteSt. Catharines, Ontario
Canada
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Windsor Regional Hospital - Ouellette Campus
Windsor Regional Hospital - Ouellette CampusWindsor, Ontario
Canada
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Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke
Centre de recherche du CIUSSS de l'Estrie - CHUS de SherbrookeSherbrooke, Quebec
Canada
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University of Calgary - Foothills Medical Centre
University of Calgary - Foothills Medical CentreCalgary, Alberta
Canada
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Victoria General
Victoria GeneralHalifax, Nova Scotia
Canada
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St Joseph's Healthcare
St Joseph's HealthcareHamilton, Ontario
Canada
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London Health Sciences Centre - Victoria Hospital
London Health Sciences Centre - Victoria HospitalLondon, Ontario
Canada
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Unity Health (St. Michael's Hospital)
Unity Health (St. Michael's Hospital)Toronto, Ontario
Canada
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Windsor Regional Hospital -Metropolitan Campus
Windsor Regional Hospital -Metropolitan CampusWindsor, Ontario
Canada
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Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)Trois-Rivières, Quebec
Canada
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Grey Nuns Community Hospital
Grey Nuns Community HospitalEdmonton, Alberta
Canada
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Lakeridge Health - Ajax Pickering
Lakeridge Health - Ajax PickeringAjax, Ontario
Canada
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Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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Lakeridge Health
Lakeridge HealthOshawa, Ontario
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Centre Hospitalier de l'Universite de Montreal (CHUM)
Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, Quebec
Canada
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St Paul's Hospital
St Paul's HospitalSaskatoon, Saskatchewan
Canada
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- Study Sponsored By
- McMaster University
- Participants Required
- More Information
- Study ID:
NCT03677102