- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677102
Fluids in Septic Shock (FISSH) (FISSH)
Fluids in Septic Shock (FISSH): a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Severe infection can lead to many complications within the human body including low blood pressure, which is called septic shock. The main treatments for septic shock are intravenous antibiotics and intravenous fluid.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Peggy Austin
- Phone Number: 22154 905-525-9140
- Email: austinp@hhsc.ca
Study Contact Backup
- Name: Bram Rochwerg, MSc,MD,FRCPC
- Phone Number: 42442 905-521-2100
- Email: rochwerg@mcmaster.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada
- Recruiting
- University of Calgary - Foothills Medical Centre
-
Contact:
- Lois Hagan, CRA
- Phone Number: (403)-944-2160
- Email: lois.hagan@ucalgary.ca
-
Principal Investigator:
- Ken Parhar, MD MSc FRCPC
-
Calgary, Alberta, Canada
- Recruiting
- University of Calgary - Rockyview General Hospital
-
Contact:
- Lois Hagan, CRA
- Phone Number: (403)-944-2160
- Email: lois.hagan@ucalgary.ca
-
Principal Investigator:
- Ken Parhar, MD MSc FRCPC
-
Edmonton, Alberta, Canada
- Recruiting
- Grey Nuns Community Hospital
-
Contact:
- Anushka Jayasekara, RC
- Email: Anushka.Jayasekara@covenanthealth.ca
-
Principal Investigator:
- Janek Senaratne, MD,MSc,ABIM,FRCPC,FACC,FESC
-
Sub-Investigator:
- Lazar Milovanovic, MD,FRCPC
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Recruiting
- Halifax Infirmary
-
Contact:
- Linda Hasties, RN, BHScN
- Phone Number: 902-499-9225
- Email: Linda.Hastie@nshealth.ca
-
Principal Investigator:
- Osama Loubani, MD,FRCPC,DABEM
-
Sub-Investigator:
- Stephen Beed, MD, FRCPC
-
Sub-Investigator:
- Volker Eichhorn, MD
-
Sub-Investigator:
- Robert Green, MD, FRCPC
-
Sub-Investigator:
- Jennifer Hancock, MD, FRCP
-
Sub-Investigator:
- Babar Haroon, MD, FRCPC
-
Sub-Investigator:
- Sarah McMullen, MD, FRCPC
-
Sub-Investigator:
- Samuel Minor, MD, FRCSC
-
Sub-Investigator:
- Laurel Murphy, MD, FRCPC
-
Sub-Investigator:
- Tony O'Leary, MD, FRCP
-
Sub-Investigator:
- Patrick Ward, MD, FRCP
-
Sub-Investigator:
- Jack Rasmussen, MD, FRCSC
-
Sub-Investigator:
- Edmund Chong-How (Edmund) Tan, MD, FRCPC
-
Sub-Investigator:
- Tobias Witter, MD
-
Halifax, Nova Scotia, Canada
- Recruiting
- Victoria General
-
Principal Investigator:
- Osama Loubani, MD,FRCPC,DABEM
-
Contact:
- Linda Hastie, RN, BHScN
- Phone Number: 902-499-9225
- Email: Linda.Hastie@nshealth.ca
-
Sub-Investigator:
- Stephen Beed, MD, FRCPC
-
Sub-Investigator:
- Volker Eichhorn, MD
-
Sub-Investigator:
- Robert Green, MD, FRCPC
-
Sub-Investigator:
- Jennifer Hancock, MD, FRCP
-
Sub-Investigator:
- Babar Haroon, MD, FRCPC
-
Sub-Investigator:
- Sarah McMullen, MD, FRCPC
-
Sub-Investigator:
- Samuel Minor, MD, FRCSC
-
Sub-Investigator:
- Laurel Murphy, MD, FRCPC
-
Sub-Investigator:
- Tony O'Leary, MD, FRCP
-
Sub-Investigator:
- Patrick Ward, MD, FRCP
-
Sub-Investigator:
- Jack Rasmussen, MD, FRCSC
-
Sub-Investigator:
- Tobias Witter, MD
-
Sub-Investigator:
- Edmund Chong-How (Edmund) Tanter, MD, FRCPC
-
-
Ontario
-
Brantford, Ontario, Canada, N3R 1G9
- Recruiting
- Brantford General Hospital
-
Contact:
- William Dechert, MSc
- Phone Number: 4531 519-752-7871
- Email: wdechert@stjosham.on.ca
-
Principal Investigator:
- Brenda Reeve, MD, FRCPC
-
Hamilton, Ontario, Canada
- Recruiting
- Hamilton General Hospital
-
Contact:
- Lori Hand, RRT
- Email: handlori@HHSC.CA
-
Principal Investigator:
- Maureen Meade, MD,FRCPC,MSc
-
Hamilton, Ontario, Canada, L8N 4A6
- Recruiting
- St Joseph's Healthcare
-
Contact:
- France Clarke, RRT
- Phone Number: 33633 905-522-1155
- Email: clarkef@mcmaster.ca
-
Principal Investigator:
- Deborah J Cook, MD,FRCPC,MSc
-
Hamilton, Ontario, Canada, L8V 1C1
- Recruiting
- Juravinski Hospital-Hamilton Health Sciences
-
Contact:
- Tina Millen, RRT
- Phone Number: 905-719-6133
- Email: millent@mcmaster.ca
-
Principal Investigator:
- Bram Rochwerg, MSc,MD,FRCPC
-
Contact:
- Bram Rochwerg, MSc,MD,FRCPC
- Phone Number: 42442 905-521-2100
- Email: rochwerg@mcmaster.ca
-
Kingston, Ontario, Canada, K7L 2V7
- Recruiting
- Kingston General Hospital
-
Contact:
- Tracy Boyd, CCRC
- Phone Number: 2608 613-549-6666
- Email: Tracy.Boyd@kingstonhsc.ca
-
Principal Investigator:
- Gordon Boyd, MD,PhD,FRCPC
-
London, Ontario, Canada, N6A 5W9
- Recruiting
- London Health Sciences Centre - Victoria Hospital
-
Contact:
- Eileen Campbell, RN
- Phone Number: 55664 519-685-8500
- Email: Eileen.Campbell@lhsc.on.ca
-
Principal Investigator:
- Ian Ball, MC,MSc,FRCPC
-
Sub-Investigator:
- Marat Slessarev, MD, FRCPC
-
London, Ontario, Canada
- Recruiting
- London Health Sciences - University Hospital
-
Contact:
- Eileen Campbell
- Email: Eileen.Campbell@lhsc.on.ca
-
Contact:
- Tracey C Bentall
- Email: TraceyC.Bentall@lhsc.on.ca
-
Principal Investigator:
- Ian Ball, MD,MSc(Epi),FRCPC
-
Sub-Investigator:
- John Basmaji, MD,FRCPC
-
Oshawa, Ontario, Canada, L1G 2B9
- Recruiting
- Lakeridge Health
-
Contact:
- Barbara Flynn, RN BScN
- Email: bflynn@lh.ca
-
Contact:
- Sarah Dulmage, ScH
- Email: sdulmage@lh.ca
-
Principal Investigator:
- Shannon Fernando, MD,MSc,FRCPC
-
Sub-Investigator:
- Karim Soliman, MD,FRCPC
-
Sub-Investigator:
- Kavita Sridhar, MD,MHSc,FRCPC
-
St Catharines, Ontario, Canada, L2S 0A9
- Recruiting
- Niagara Health, St Catharines Site
-
Contact:
- Lisa Patterson, RC
- Email: Lisa.Patterson@niagarahealth.on.ca
-
Principal Investigator:
- Erick Duan, MD, FRCPC
-
Sub-Investigator:
- Jennifer Tsang, MD,PhD,FRCPC
-
Toronto, Ontario, Canada, M5G 1X5
- Recruiting
- Mount Sinai Hospital
-
Contact:
- Sumesh Shah, CCRP
- Phone Number: 8445 416-586-4800
- Email: Sumesh.Shah@SinaiHealthSystem.ca
-
Principal Investigator:
- SANGEETA MEHTA, MD,FRCPC
-
Toronto, Ontario, Canada
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Nicole Marinoff, RN, CCRP
- Email: Nicole.Marinoff@sunnybrook.ca
-
Principal Investigator:
- Neill Adhikari, MDCM, MSc.
-
Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- Unity Health (St. Michael's Hospital)
-
Contact:
- Marlene Santos, MD, ACRP
- Phone Number: 2322 416-864-6060
- Email: Marlene.Santos@unityhealth.to
-
Principal Investigator:
- Karen E Burns, MD,FRCPC
-
Sub-Investigator:
- Jan Friedrich, MD, PhD, MSc
-
-
Quebec
-
Montreal, Quebec, Canada, H4J 1C5
- Recruiting
- Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal
-
Contact:
- Virginie Williams, PhD
- Phone Number: 583-3272 514 338 2222
- Email: virginie.williams.cnmtl@ssss.gouv.qc.ca
-
Principal Investigator:
- Karim Serri, BSc,MD
-
Montréal, Quebec, Canada
- Recruiting
- Centre Hospitalier de l'Université de Montréal (CHUM)
-
Contact:
- Andrea Gagnon-Hamelin
- Email: andrea.gagnon-hamelin.chum@ssss.gouv.qc.ca
-
Principal Investigator:
- Emmanuel Charbonney, MD, PhD
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke
-
Contact:
- Marie-Pier Bouchard, RA
- Email: marie-pier.bouchard.ciussse-chus@ssss.gouv.qc.ca
-
Principal Investigator:
- François Lamontagne, MD,MSc
-
Sub-Investigator:
- Fred D'aragon, MD, MSc
-
Trois-Rivières, Quebec, Canada
- Recruiting
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ)
-
Contact:
- Alice Lefebvre, RC
- Phone Number: 64820 819 697-3333
- Email: alice.lefebvre@ssss.gouv.qc.ca
-
Principal Investigator:
- Jean-Francois Naud, MD
-
-
-
-
-
Riyadh, Saudi Arabia
- Recruiting
- King Faisal Specialist Hospital & Research Centre
-
Contact:
- Samar Nouri, CRC
- Email: snouri@kfhrc.edu.sa
-
Principal Investigator:
- Zainab Al Duhailib, MD
-
Riyadh, Saudi Arabia
- Recruiting
- King Abdulaziz Medical City- Riyadh (KAMC-R)
-
Contact:
- Felwa Bin Humaid, BSc
-
Principal Investigator:
- Sara Aldekhyl, MBBS,ABIM,FRCPc,MedEd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: higher chloride solutions
higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)
|
Normal saline (chloride concentration 154 mmol/L)
|
Active Comparator: lower chloride solutions
lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
|
Ringer's Lactate (chloride concentration 110 mmol/L)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day Mortality
Time Frame: up to 30 days
|
We expect that if a difference in survival is demonstrated, that this will be evident within 30 days
|
up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Kidney Injury
Time Frame: up to 30 days
|
Development of stage 2 or worse acute kidney injury (AKI) according to KIDGO guidelines on serum creatinine criteria
|
up to 30 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital/ICU length of stay
Time Frame: up to 30 days
|
length of hospital/ICU stay up to 30 days
|
up to 30 days
|
Ventilator free days
Time Frame: censored at 30 days
|
Number of ventilator free days
|
censored at 30 days
|
Number of days requiring vasoactive agents
Time Frame: up to 30 days
|
defined as the number of days requiring great than or equal to 2 hours of intravenous vasopressor support
|
up to 30 days
|
Incidence of biochemical abnormalities during study period
Time Frame: up to 30 days
|
any serum blood test results showing hyperchloremia, hyperkalemia, hypernatremia, or acidosis
|
up to 30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bram Rochwerg, MSc,MD,FRCPC, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1515
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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