Fluids in Septic Shock (FISSH)

Phase 2

Recruiting

• Conditions: Sepsis, Septic Shock
• Interventions: Other: lower chloride crystalloid; Other: higher chloride crystalloid

• Registration Number: NCT03677102
• Lead Sponsor: McMaster University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-27
• Study Start: 2018-09-09
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-11-28
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1096

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lower chloride solutions	lower chloride crystalloid	lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
higher chloride solutions	higher chloride crystalloid	higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)

Primary Outcome Measures

Name	Time	Method
30-day Mortality	up to 30 days	We expect that if a difference in survival is demonstrated, that this will be evident within 30 days

Secondary Outcome Measures

Name	Time	Method
Acute Kidney Injury	up to 30 days	Development of stage 2 or worse acute kidney injury (AKI) according to KIDGO guidelines on serum creatinine criteria

Trial Locations

Locations (23)

Juravinski Hospital-Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

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

St Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Brantford General Hospital; 🇨🇦 Brantford, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, 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

Centre Hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada

Centre intégré Universitaire de santé et de services sociaux du Nord de l'île de Montréal; 🇨🇦 Montreal, 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

Centre de recherche du CIUSSS de l'Estrie - CHUS de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

King Abdulaziz Medical City- Riyadh (KAMC-R); 🇸🇦 Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Centre; 🇸🇦 Riyadh, Saudi Arabia

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada

Victoria General; 🇨🇦 Halifax, Nova Scotia, Canada