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Crystalloid Solution

Crystalloid Solutions for Septic Shock (FISSH Trial)

Phase 2 & 3
Recruiting
Led By Bram Rochwerg, MSc,MD,FRCPC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
are within 6 hours of hospital admission or critical care response team consultation
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)
Must not have
10% of body surface area acute burn injury
bleeding/hemorrhage as likely cause of hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a different type of fluid is safer and more effective for patients with serious infections. It aims to see if this new fluid can reduce harm to organs and help patients live longer.

Who is the study for?
The FISSH trial is for patients aged 16 or older who are suspected of having an infection, within 6 hours of hospital admission, and need ICU care due to low blood pressure or organ issues after initial fluid treatment. Excluded are those with major burns, bleeding as the main issue, no commitment to life support, prior enrollment in FISSH or similar trials, end-stage kidney disease on dialysis, brain bleeds/hypertension during current stay.
What is being tested?
This study compares two types of IV fluids used in septic shock: one with higher chloride levels (normal saline) and another with lower chloride levels. It's a randomized controlled trial focusing on how these fluids affect mortality rates and acute kidney injury.
What are the potential side effects?
While specific side effects aren't listed for this trial, generally IV fluids can cause reactions like allergic responses or infections at the injection site. High chloride solutions may also increase risk of kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was admitted to the hospital or seen by a critical care team less than 6 hours ago.
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I am 16 or older and need fluids for low blood pressure or poor organ blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have burns covering 10% of my body.
Select...
My low blood pressure is likely due to bleeding.
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I am on dialysis or have end-stage kidney disease.
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I had a brain bleed or high brain pressure during my recent hospital stay.
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I was moved to the ICU right after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30-day Mortality
Secondary study objectives
Acute Kidney Injury
Other study objectives
Hospital/ICU length of stay
Incidence of biochemical abnormalities during study period
Number of days requiring vasoactive agents
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: lower chloride solutionsActive Control1 Intervention
lower chloride crystalloid (Ringer's lactate - chloride concentration 110 mmol/L)
Group II: higher chloride solutionsActive Control1 Intervention
higher chloride crystalloid (Normal saline - chloride concentration 154 mmol/L)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sepsis include fluid resuscitation, vasopressors, and corticosteroids. Fluid resuscitation, often using crystalloids like normal saline or low chloride solutions, aims to restore intravascular volume, improve tissue perfusion, and prevent organ failure. Low chloride solutions are being studied for their potential to reduce mortality and acute kidney injury (AKI) by minimizing hyperchloremic acidosis, which can exacerbate kidney damage. Vasopressors, such as norepinephrine, are used to maintain adequate blood pressure and ensure vital organ perfusion when fluids alone are insufficient. Corticosteroids may be administered to modulate the inflammatory response and improve hemodynamic stability. These treatments are crucial for sepsis patients as they address the underlying pathophysiological disturbances, improve survival rates, and reduce complications.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,614,132 Total Patients Enrolled
4 Trials studying Sepsis
1,741 Patients Enrolled for Sepsis
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
27,331 Total Patients Enrolled
2 Trials studying Sepsis
672 Patients Enrolled for Sepsis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,516,977 Total Patients Enrolled
11 Trials studying Sepsis
9,320 Patients Enrolled for Sepsis
~153 spots leftby Nov 2025