Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1096 participants
INTERVENTIONAL
2018-09-09
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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higher chloride solutions
higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)
higher chloride crystalloid
Normal saline (chloride concentration 154 mmol/L)
lower chloride solutions
lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
lower chloride crystalloid
Ringer's Lactate (chloride concentration 110 mmol/L)
Interventions
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higher chloride crystalloid
Normal saline (chloride concentration 154 mmol/L)
lower chloride crystalloid
Ringer's Lactate (chloride concentration 110 mmol/L)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Bram Rochwerg, MSc,MD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
University of Calgary - Rockyview General Hospital
Calgary, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Halifax Infirmary
Halifax, Nova Scotia, Canada
Victoria General
Halifax, Nova Scotia, Canada
Cape Breton Regional Hospital
Sydney, Nova Scotia, Canada
Lakeridge Health - Ajax Pickering
Ajax, Ontario, Canada
Brantford General Hospital
Brantford, Ontario, Canada
St Joseph's Healthcare
Hamilton, Ontario, Canada
Juravinski Hospital-Hamilton Health Sciences
Hamilton, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
London Health Sciences - University Hospital
London, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Niagara Health, St Catharines Site
St. Catharines, Ontario, Canada
Unity Health (St. Michael's Hospital)
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Windsor Regional Hospital - Ouellette Campus
Windsor, Ontario, Canada
Windsor Regional Hospital -Metropolitan Campus
Windsor, Ontario, Canada
Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal
Montreal, Quebec, 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, Canada
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)
Trois-Rivières, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
St Paul's Hospital
Saskatoon, Saskatchewan, Canada
King Abdulaziz Medical City- Riyadh (KAMC-R)
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Cheryl Furey, RN, BScN
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1515
Identifier Type: -
Identifier Source: org_study_id
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