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Completed

NCT Number: NCT02748382

Fluids in Sepsis and Septic Shock

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 RCT evidence. Editorials published in leading critical care journals have called for RCT's to address this important clinical question. The proposed feasibility RCT will investigate the feasibility of a large-scale trial directly comparing low chloride versus normal chloride for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Juravinski Hospital-Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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 taht 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). Although, the investigators plan for a larger trial looking at patient-important outcomes such as rate of death, kidney failure and length of stay in the ICU the investigators think it's important to start with a feasibility study. If the investigators are able to show a larger trial is feasible then the investigators will apply for further funding and use the lessons learned from this pilot to optimize the larger study. The larger study has the potential to guide the care of critically ill patients with infection worldwide.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be at least 16 years of age
  • Within 6 hours from presentation to hospital or activation of MET/RACE team to ward
  • Requires fluid resuscitation for refractory hypotension OR organ hypoperfusion
  • refractory hypotension definition - sBP <90 OR MAP <65 after 1L bolus given over 1 hour or less
  • organ hypoperfusion - lactate >4
  • Suspected source of infection as etiology for hypotension
  • Treating physician anticipates patient will require admission to ICU

Exclusion criteria

  • Intracranial bleed or intracranial hypertension during this hospital admission
  • Acute burn injury (>10% body surface area)
  • Bleeding/hemorrhage as likely cause of hypotension
  • Plan in place to change goals of care to palliation
  • Previously enrolled in FISSH
  • Previously enrolled in confounding trial
  • Transfer from another hospital or facility
  • Admission directly from the operating room or PACU

Treatment and study plan

higher chloride crystalloid

Other

Normal saline

higher chloride albumin

Other

5% Octalbin

lower chloride crystalloid

Other

Ringers Lactate

lower chloride albumin

Other

5% Plasbumin

Primary outcomes

  1. Consent Rate

    Time frame: 12 months

    Consent rate will be considered adequate if greater than 70% of substitute decision makers (SDMs) or patients when approached for consent choose to participate.

  2. Patient Recruitment

    Time frame: 12 months

    Successful recruitment will be defined as achieving enrolment of 50 patients over the 12-month study period. This works out to approximately 1 patient/center/month. Once the pilot trial begins, the screening logs will be reviewed at all three study centers by the study steering committee on a monthly basis. We will record exclusions and reasons for physician refusals.

  3. Protocol Adherence

    Time frame: 12 months

    Successful adherence will be defined as patients receiving at least 75% study fluid of all intravenous fluid that is administered in the ICU excluding blood products and medication infusions.

Secondary outcomes

  1. Hospital length of stay

    Time frame: Duration of index hospital stay censored at 90 days.

  2. Hospital mortality

    Time frame: hospital stay or up to 90 days

    Mortality during index hospitalization censored at 90 days.

  3. Renal replacement therapy use

    Time frame: RRT use during index hospital stay censored at 90 days.

    Any use of renal replacement therapy including hemodialysis, peritoneal dialysis or continuous renal replacement. This will be reported as a dichotomous outcome.

  4. ICU length of stay

    Time frame: Duration of index ICU stay censored at 90 days.

  5. Hyperkalemia

    Time frame: Incidence during index ICU stay or up to 30 days

    Number of participants with any serum potassium value >5mmol/L.

  6. Acidosis

    Time frame: Incidence during index ICU stay or up to 30 days

    Number of participants with any serum pH <7.20

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

Fluids in Sepsis and Septic Shock: A Pilot Randomized Controlled Trial

Acronym: FISSH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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