Fluids in Septic Shock (FISSH): a Randomized Controlled Trial

Who is this study for? Children and adult patients with sepsis
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Lakeridge Health - Ajax Pickering
RECRUITING
Ajax
Brantford General Hospital
RECRUITING
Brantford
University of Calgary - Foothills Medical Centre
RECRUITING
Calgary
University of Calgary - Rockyview General Hospital
RECRUITING
Calgary
Grey Nuns Community Hospital
RECRUITING
Edmonton
Halifax Infirmary
RECRUITING
Halifax
Victoria General
RECRUITING
Halifax
Hamilton General Hospital
RECRUITING
Hamilton
Juravinski Hospital-Hamilton Health Sciences
RECRUITING
Hamilton
St Joseph's Healthcare
RECRUITING
Hamilton
Kingston General Hospital
RECRUITING
Kingston
London Health Sciences - University Hospital
RECRUITING
London
London Health Sciences Centre - Victoria Hospital
RECRUITING
London
Centre Hospitalier de l'Universite de Montreal (CHUM)
RECRUITING
Montreal
Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal
RECRUITING
Montreal
Lakeridge Health
RECRUITING
Oshawa
Royal University Hospital
RECRUITING
Saskatoon
St Paul's Hospital
RECRUITING
Saskatoon
Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke
RECRUITING
Sherbrooke
Niagara Health, St Catharines Site
RECRUITING
St. Catharines
Cape Breton Regional Hospital
RECRUITING
Sydney
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Unity Health (St. Michael's Hospital)
RECRUITING
Toronto
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)
RECRUITING
Trois-rivières
Windsor Regional Hospital - Ouellette Campus
RECRUITING
Windsor
Windsor Regional Hospital -Metropolitan Campus
RECRUITING
Windsor
Saudi Arabia
King Abdulaziz Medical City- Riyadh (KAMC-R)
RECRUITING
Riyadh
King Faisal Specialist Hospital & Research Centre
RECRUITING
Riyadh
Contact Information
Primary
Bram Rochwerg, MSc,MD,FRCPC
rochwerg@mcmaster.ca
905-521-2100
Backup
Peggy Austin
austinp@hhsc.ca
905-525-9140
Time Frame
Start Date: 2018-09-09
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 1096
Treatments
Active_comparator: higher chloride solutions
higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)
Active_comparator: lower chloride solutions
lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
Leads: McMaster University

This content was sourced from clinicaltrials.gov