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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights

FISSH Trial Summary

This trial will compare the effects of low chloride and normal chloride solutions on mortality and AKI in septic shock patients.

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.Check my eligibility
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.See study design
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.

FISSH Trial Eligibility Criteria

Inclusion Criteria

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

FISSH Trial 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

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

FISSH 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)

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,595,920 Total Patients Enrolled
4 Trials studying Sepsis
1,741 Patients Enrolled for Sepsis
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
25,659 Total Patients Enrolled
2 Trials studying Sepsis
672 Patients Enrolled for Sepsis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,012 Total Patients Enrolled
10 Trials studying Sepsis
6,780 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial being conducted in multiple locations within the city?

"There are 17 sites where this trial is being conducted, they are: Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) in Trois-Rivières, Brantford General Hospital in Brantford, Hamilton General Hospital in Hamilton, and 14 other locations."

Answered by AI

Could you give an estimate as to how many individuals are currently enrolled in this trial?

"Yes, recruitment for this trial is still open according to the latest update on clinicaltrials.gov. The posting date was September 9th, 2018, and the 17 locations are recruiting 1096 patients in total."

Answered by AI

Can patients sign up for this experiment right now?

"Yes, you are correct. The trial is currently ongoing and recruiting patients from 17 different sites. 1096 individuals are needed for the study."

Answered by AI

What are the objectives of this experiment?

"The main metric that will be used to assess the success of this 30-day clinical trial is 30-day mortality rates. Additionally, hospital/ICU mortality rates, serum potassium levels outside the normal range, and duration of vasoactive agent use will be monitored as secondary outcomes."

Answered by AI
~242 spots leftby Nov 2025