Fluids in Sepsis and Septic Shock

NCT02748382 | Completed Phase 2

• 1 other identifier: 1636
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (3)

• Consent Rate

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

  12 months

• Patient Recruitment

  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.

  12 months

• Protocol Adherence

  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.

  12 months

Secondary Outcomes (6)

• Hospital length of stay

  Duration of index hospital stay censored at 90 days.

• Hospital mortality

  hospital stay or up to 90 days

• Renal replacement therapy use

  RRT use during index hospital stay censored at 90 days.

• ICU length of stay

  Duration of index ICU stay censored at 90 days.

• Hyperkalemia

  Incidence during index ICU stay or up to 30 days

Study Arms (2)

higher chloride solutions

ACTIVE COMPARATOR

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

Other: higher chloride crystalloid; Other: higher chloride albumin

lower chloride solutions

ACTIVE COMPARATOR

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

Other: lower chloride crystalloid; Other: lower chloride albumin

Interventions

higher chloride crystalloid OTHER

Normal saline

higher chloride solutions

higher chloride albumin OTHER

5% Octalbin

higher chloride solutions

lower chloride crystalloid OTHER

Ringers Lactate

lower chloride solutions

lower chloride albumin OTHER

5% Plasbumin

lower chloride solutions

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Juravinski Hospital-Hamilton Health Sciences

Hamilton, Ontario, L8V 1C1, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 3H5, Canada

Location

Related Publications (1)

• 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.

  PMID: 28729329 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 22, 2016
• Study Start: August 18, 2016
• Primary Completion: August 19, 2017
• Study Completion: August 19, 2017
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)