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Crystalloid FLUID Choices for Resuscitation of Hospitalized Patients (FLUID)

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ClinicalTrials.gov Identifier: NCT04512950
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The aim of the FLUID Trial is to conduct a pragmatic, multi-centre, open label randomized cluster cross-over trial (RCT) to determine whether fluid administration with 0.9% saline as compared to Ringer's lactate decreases death or re-admission to hospital with 90 days of the index admission.

Condition or disease Intervention/treatment Phase
Fluid Therapy Drug: Ringer's lactate Drug: 0.9% saline Phase 4

Detailed Description:

Crystalloid fluids are used extensively for acutely ill patients who are admitted to hospital. Two fluids most commonly used are 0.9% saline and Ringer's Lactate. Both are used to rehydrate patients, restore fluid volume and help stabilize blood pressure and failing organ and both have been used for several decades. Until recently, it was thought the fluids are essentially equivalent other than some minor differences related to the concentration of salt components (sodium and chloride) and buffers (Ringer's Lactate has lactate as a buffer). The safety of 0.9% saline is now being questioned due to its high chloride content and its association with the development of hyperchloremic metabolic acidosis. Until recently, the evidence base supporting the superiority of Ringer's Lactate has been derived from observational studies. Two recent pilot studies in critically ill patients comparing 0.9% saline to balanced crystalloid fluids (Ringer's lactate and/or Plasma-Lyte, another balanced crystalloid) did not detect clinical outcome differences between the fluid groups, but the trials were not powered to do so. Furthermore, two multiple period cluster cross-over studies conducted at one institution comparing 0.9% saline to balanced crystalloids (Ringer's lactate and Plasma-Lyte) in the emergency department (ED) and intensive care unit (ICU) found small differences in a composite outcome which included death, requirement for dialysis or persistent renal dysfunction, in favor of balanced crystalloids. Authors and editorialists now urge the conduct of large multi-centre randomized trials, with longer-term patient centred outcomes supported by health economic evaluations to provide confirmatory evidence to guide future clinical practice and resource allocation related to these usual care crystalloid fluids.

Small differences in clinical outcomes between crystalloid resuscitation fluids are highly relevant. Furthermore, small absolute differences in important clinical outcomes may translate into substantial savings to hospitals and the health care system. The FLUID trial will determine if there are differences in the clinically important outcomes of death and hospital re-admissions. FLUID is novel in its design because it is a hospital wide pragmatic cluster cross-over comparative effectiveness trial that will be conducted in both academic and community sites which will use provincial health administrative data available through the Institute of Clinical Evaluative Sciences (ICES) for all clinical data collection. Our trial will answer this fundamental fluid resuscitation question and determine if Ringer's Lactate is superior to 0.9% saline at much lower cost in comparison to an individual patient randomized controlled trial (RCT), or even a conventional cluster RCT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cluster Cross Over
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crystalloid FLUID Choices for Resuscitation of Hospital Patients: A Pragmatic Cluster Cross Over Trial
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Ringer's lactate
administered as infusions or boluses as per the treating physician
Drug: Ringer's lactate
Half of the hospitals will be randomized to Ringer's Lactate for a 12 week study period; after a 2 week run-out, the study fluid will be switched to 0.9% saline for another 12 week study period, followed by a 2 week run-out.
Other Name: Lactated Ringer's

Active Comparator: 0.9% Saline
administered as infusions or boluses as per the treating physician
Drug: 0.9% saline
Half of the hospitals will be randomized to 0.9% saline for a 12 week study period; after a 2 week run-out, the study fluid will be switched to Ringer's Lactate for another 12 week study period, followed by a 2 week run-out.
Other Name: sodium chloride 0.9%




Primary Outcome Measures :
  1. Number of participants that died or were readmitted to hospital [ Time Frame: 90 days from index hospital admission ]
    the number of deaths or readmission to hospital


Secondary Outcome Measures :
  1. Number of participants that died [ Time Frame: 90 days from index hospital admission ]
    The number of deaths

  2. Number of participants re-admitted to hospital [ Time Frame: 90 days from index hospital admission ]
    the number of participants re-admitted to any hospital in Ontario

  3. Number of participants that required dialysis or continuous renal replacement therapy [ Time Frame: 90 days from index hospital admission ]

    the number of participants who required the initiation of dialysis or continuous renal

    replacement therapy in the first 90 days from index hospital admission with no history of renal disease requiring dialysis in the previous 6 months


  4. Number of participants that required re-intubation in the post anesthetic care unit operative period [ Time Frame: during index hospital admission ]
    the number of post operative participants who failed their initial extubation and required re-intubation in the post anesthetic care unit

  5. Duration of hospitalization [ Time Frame: Up to 90 Days from index hospital admission ]
    the number of days participants were hospitalized during index admission

  6. ED visits [ Time Frame: number of index ED visits within 90 days of index hospital admission ]
    number of index ED visits

  7. Discharged to a facility other than home [ Time Frame: 90 days from index hospital admission ]
    number of participants discharged from index hospitalization to a facility other than home


Other Outcome Measures:
  1. Incremental cost, life-year saved, quality-adjusted life-year (QALY) [ Time Frame: 90 days from index hospitalization ]
    cost per life-year saved and cost per QALY gained



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

● All adult and pediatric patients with an index admission to the participating hospitals during study periods

Exclusion Criteria:

  • neonates
  • physicians may opt out of the use of the allocated study fluid for a specific patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512950


Contacts
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Contact: Tracy McArdle, RN BScN 613 737 8899 ext 73837 tmcardle@ohri.ca
Contact: Lauralyn McIntyre, MD MHSc 613 737 8899 ext 73231 lmcintyre@ohri.ca

Locations
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Canada, Ontario
University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Daniel Banbridge, MD         
Contact: Tracy Bentall         
Victoria Hospital Completed
London, Ontario, Canada
Montfort Hospital Completed
Ottawa, Ontario, Canada, K1K 0T2
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Lauralyn McIntyre, MS MHSc Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04512950    
Other Study ID Numbers: 0778
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: all data will be obtained from the Institute of Clinical Evaluative Sciences - no individual patient data will be obtained

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Ringer's Lactate
0.9% saline
Resuscitation
Hypovolemia
Rehydration