What side effects are associated with this type of intervention?

Common treatments for sepsis include fluid resuscitation, antibiotics, and supportive care. Fluid resuscitation with normal saline can lead to hyperchloremic metabolic acidosis and potential kidney injury, while balanced solutions like lactated Ringer's are associated with fewer kidney-related side effects but can cause metabolic alkalosis. Antibiotics, essential for treating sepsis, may cause allergic reactions, gastrointestinal issues, and contribute to antibiotic resistance. Supportive care, including vasopressors and mechanical ventilation, carries risks such as arrhythmias and ventilator-associated lung injury.

What prior FDA approvals exist?

The FDA has approved various treatments for sepsis, primarily focusing on fluid resuscitation and vasopressors. For fluid management, crystalloids like normal saline and balanced solutions such as Ringer's lactate are commonly used. Although albumin solutions have been studied, they have not shown a clear benefit over crystalloids and are more costly. Vasopressors like norepinephrine are preferred for maintaining blood pressure in septic shock. The trial on low chloride solutions aims to explore whether reducing chloride content in resuscitation fluids can lower mortality and acute kidney injury (AKI) in septic patients, but this specific approach has not yet been a focus of FDA approvals.

What other types of research exist?

Promising novel alternatives to low chloride solutions for sepsis patients include balanced electrolyte solutions such as Plasma-Lyte, which have shown benefits in reducing mortality and acute kidney injury (AKI). Hypertonic saline is another option that has been evaluated for its potential benefits in fluid resuscitation. Additionally, the use of colloids and the careful administration of vasopressors may provide complementary benefits in the management of sepsis.

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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:

Select...

I have burns covering 10% of my body.

Select...

My low blood pressure is likely due to bleeding.

Select...

I am on dialysis or have end-stage kidney disease.

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

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)

0 / 7Eligibility criteria met

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.