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NCT02748382: FISSH

Fluids in Sepsis and Septic Shock

Completed Phase 2, PHASE3 Last updated 29 August 2018
What this trial tests

Phase 2, PHASE3 trial testing higher chloride crystalloid in Sepsis in 50 participants. Completed in 19 August 2017.

Timeline
18 August 2016
Primary endpoint
19 August 2017
19 August 2017

Quick facts

Lead sponsorMcMaster University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment50
Start date18 August 2016
Primary completion19 August 2017
Estimated completion19 August 2017
Sites2 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

McMaster University

Who can join

16 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial.
    Rochwerg B, Millen T, Austin P, Zeller M, et al · · 2017 · cited 12× · PMID 28729329 · DOI 10.1136/bmjopen-2017-017602

Verify or expand the search:

Other trials of higher chloride crystalloid

Trials testing the same drug.

Other recruiting trials for Sepsis

Currently open trials in the same condition.

Other McMaster University trials

Trials by the same sponsor.

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Data sources for this page

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