Fluids in Sepsis and Septic Shock

NCT ID: NCT02748382

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-18
• Study Completion Date: 2017-08-19

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 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.

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 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.

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

higher chloride solutions

higher chloride crystalloid (Normal saline) higher chloride albumin (5% Octalbin)

Group Type: ACTIVE_COMPARATOR

higher chloride crystalloid

Intervention Type: OTHER

Normal saline

higher chloride albumin

Intervention Type: OTHER

5% Octalbin

lower chloride solutions

lower chloride crystalloid (Ringer's lactate) lower chloride albumin (5% Plasbumin)

Group Type: ACTIVE_COMPARATOR

lower chloride crystalloid

Intervention Type: OTHER

Ringers Lactate

lower chloride albumin

Intervention Type: OTHER

5% Plasbumin

Interventions

higher chloride crystalloid

Normal saline

Intervention Type: OTHER

higher chloride albumin

5% Octalbin

Intervention Type: OTHER

lower chloride crystalloid

Ringers Lactate

Intervention Type: OTHER

lower chloride albumin

5% Plasbumin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient must be at least 16 years of age

2. Within 6 hours from presentation to hospital or activation of MET/RACE team to ward

3. 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

4. Suspected source of infection as etiology for hypotension

5. Treating physician anticipates patient will require admission to ICU

Exclusion Criteria

1. Intracranial bleed or intracranial hypertension during this hospital admission

2. Acute burn injury (>10% body surface area)

3. Bleeding/hemorrhage as likely cause of hypotension

4. Plan in place to change goals of care to palliation

5. Previously enrolled in FISSH

6. Previously enrolled in confounding trial

7. Transfer from another hospital or facility

8. Admission directly from the operating room or PACU

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Juravinski Hospital-Hamilton Health Sciences

Hamilton, Ontario, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

Rochwerg B, Millen T, Austin P, Zeller M, D'Aragon F, Jaeschke R, Masse MH, Mehta S, Lamontagne F, Meade M, Guyatt G, Cook DJ; Canadian Critical Care Trials Group. Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial. BMJ Open. 2017 Jul 20;7(7):e017602. doi: 10.1136/bmjopen-2017-017602.

Reference Type: DERIVED

PMID: 28729329 (View on PubMed)

Other Identifiers

1636

Identifier Type: -

Identifier Source: org_study_id