Fluids in Septic Shock (FISSH) (FISSH)
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| ClinicalTrials.gov Identifier: NCT03677102 |
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Recruitment Status :
Recruiting
First Posted : September 19, 2018
Last Update Posted : December 17, 2021
|
Sponsor:
McMaster University
Collaborators:
The Physicians' Services Incorporated Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sepsis, Septic Shock | Other: higher chloride crystalloid Other: lower chloride crystalloid | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1096 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Fluids in Septic Shock (FISSH): a Randomized Controlled Trial |
| Actual Study Start Date : | September 9, 2018 |
| Estimated Primary Completion Date : | July 1, 2023 |
| Estimated Study Completion Date : | August 1, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Shock
Drug Information available for:
Chlorine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: higher chloride solutions
higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)
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Other: higher chloride crystalloid
Normal saline (chloride concentration 154 mmol/L) |
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Active Comparator: lower chloride solutions
lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
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Other: lower chloride crystalloid
Ringer's Lactate (chloride concentration 110 mmol/L) |
Primary Outcome Measures :
- Stage 2 or worse acute kidney injury (AKI) [ Time Frame: up to 30 days ]Development of stage 2 or worse acute kidney injury (AKI) according to KIDGO guidelines based strictly on serum creatinine criteria.
Secondary Outcome Measures :
- hospital/ICU mortality [ Time Frame: up to 30 days ]hospital/ICU mortality up to 30 days
- hospital/ICU length of stay [ Time Frame: up to 30 days ]length of hospital/ICU stay up to 30 days
- ventilator free days [ Time Frame: censored at 30 days ]number of ventilator free days, censored at 30 day
- number of days requiring vasoactive agents [ Time Frame: duration of time requiring intravenous vasopressors (censored at 30 days) ]duration of time requiring vaso-active agents censored at 30 days
- Number of participants with a serum potassium over 5mEq/L or under 3.5mEq/L [ Time Frame: up to 30 days ]at any time
- Number of participants with a serum sodium over 145mEq/L or under 130mEq/L [ Time Frame: up to 30 days ]at any time
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677102
Contacts
| Contact: Bram Rochwerg, MSc,MD,FRCPC | 905-521-2100 ext 42111 | rochwerg@mcmaster.ca | |
| Contact: Peggy Austin | 905-525-9140 ext 22154 | austinp@hhsc.ca |
Locations
| Canada, Ontario | |
| Brantford General Hospital | Recruiting |
| Brantford, Ontario, Canada, N3R 1G9 | |
| Contact: Brenda Reeve, MD,FRCPC 519-751-5508 acescholes@yahoo.com | |
| Contact: William Dechert 519-752-7871 ext 4531 wdechert@stjosham.on.ca | |
| St Joseph's Healthcare | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Deborah Cook, MD,FRCPC,MSc 905-525-9140 ext 22900 debcook@mcmaster.ca | |
| Contact: France Clarke, RRT 905-522-1155 ext 33633 clarkef@mcmaster.ca | |
| Juravinski Hospital-Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8V 1C1 | |
| Contact: Bram Rochwerg, MSc,MD,FRCPC 905 515 2121 bram.rochwerg@mcmaster.ca | |
| Contact: Tina Millen, RRT 905-719-6133 millent@mcmaster.ca | |
| Principal Investigator: Bram Rochwerg, MSc,MD,FRCPC | |
| Hamilton General Hospital | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Maureen Meade, MD,FRCPC,MSc 905-525-9140 ext 22900 meadema@HHSC.CA | |
| Contact: Lori Hand, RRT handlori@HHSC.CA | |
| Kingston General Hospital | Not yet recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Gordon Boyd, MD,PhD,FRCPC 613-549-6666 ext 6228 gordon.boyd@kingstonhsc.ca | |
| Contact: Tracy Boyd 613-549-6666 ext 2608 Tracy.Boyd@kingstonhsc.ca | |
| London Health Sciences Centre - Victoria Hospital | Not yet recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Ian Dr Ball, MD,MSc,FRCPC 519-685-8500 ext 71513 Ian.Ball@lhsc.on.ca | |
| Contact: Eileen Campbell 519-685-8500 ext 55664 Eileen.Campbell@lhsc.on.ca | |
| Niagara Health, St Catharines Site | Recruiting |
| St Catharines, Ontario, Canada, L2S 0A9 | |
| Contact: Erick Duan, MD, FRCPC 905-869-6551 erick.duan@medportal.ca | |
| St. Michael's Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Karen E Burns, MD,FRCPC BurnsK@smh.ca | |
| Contact: Marlene Santos Santosmar@smh.ca | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Contact: SANGEETA MEHTA, MD,FRCPC 416-586-4800 ext 4604 geeta.mehta@SinaiHealthSystem.ca | |
| Contact: Sumesh Shah, CCRP 416-586-4800 ext 8445 Sumesh.Shah@SinaiHealthSystem.ca | |
| Canada, Quebec | |
| Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: François Lamontagne, MD,MSc 819-346-1110 ext 14173 Francois.Lamontagne@USherbrooke.ca | |
| Contact: Marie-Hélène Masse, RA 819-346-1110 ext 14173 marie-pier.bouchard.ciussse-chus@ssss.gouv.qc.ca | |
| Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) | Recruiting |
| Trois-Rivières, Quebec, Canada, G8Z 3R9 | |
| Contact: Jean-François Naud, MD 819-697-3333 ext 63547 alakazou007@hotmail.com | |
| Contact: Danielle Tapps, RC 819-697-3333 ext 63547 danielle_tapps@ssss.gouv.qc.ca | |
| Saudi Arabia | |
| King Faisal Specialist Hospital & Research Centre | Recruiting |
| Riyadh, Saudi Arabia | |
| Contact: Mahmoud Abu-Riash maburiash@kfshrc.edu.sa | |
| Principal Investigator: Zainab Al Duhailib | |
Sponsors and Collaborators
McMaster University
The Physicians' Services Incorporated Foundation
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Bram Rochwerg, MSc,MD,FRCPC | McMaster University |
Study Documents (Full-Text)
Documents provided by McMaster University:
Documents provided by McMaster University:
Study Protocol and Statistical Analysis Plan [PDF] April 20, 2018
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT03677102 |
| Other Study ID Numbers: |
1515 |
| First Posted: | September 19, 2018 Key Record Dates |
| Last Update Posted: | December 17, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Shock, Septic Shock Pathologic Processes Sepsis |
Infections Systemic Inflammatory Response Syndrome Inflammation |