Crystalloid FLUID Choices for Resuscitation of Hospitalized Patients

NCT04512950 | Completed Phase 4

• 1 other identifier: 0778
• Study Type: interventional
• Target: 43,626
• Locations: 1 country
• Sites: 7

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.

Conditions

Fluid Therapy

Keywords

Ringer's Lactate; 0.9% saline; Resuscitation; Hypovolemia; Rehydration

Outcome Measures

Primary Outcomes (1)

• Number of participants that died or were readmitted to hospital

  the number of deaths or readmission to hospital

  90 days from index hospital admission

Secondary Outcomes (8)

• Number of participants that died

  90 days from index hospital admission

• Number of participants re-admitted to hospital

  90 days from index hospital admission

• Number of participants that required dialysis or continuous renal replacement therapy

  90 days from index hospital admission

• Number of participants that required re-intubation in the post anesthetic care unit operative period

  Up to 90 days after the initial operation during index hospital admission

• Duration of hospitalization

  Up to 90 Days from index hospital admission

Other Outcomes (1)

• Incremental cost, life-year saved, quality-adjusted life-year (QALY)

  90 days from index hospitalization

Study Arms (2)

Ringer's lactate

ACTIVE COMPARATOR

administered as infusions or boluses as per the treating physician

Drug: Ringer's lactate

0.9% Saline

ACTIVE COMPARATOR

administered as infusions or boluses as per the treating physician

Drug: 0.9% saline

Interventions

Ringer's lactate DRUG

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.

Also known as: Lactated Ringer's

Ringer's lactate

0.9% saline DRUG

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.

Also known as: sodium chloride 0.9%

0.9% Saline

Eligibility Criteria

• Age: 29 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (7)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Montfort Hospital

Ottawa, Ontario, K1K 0T2, Canada

Location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1V7C6, Canada

Location

The Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Queensway Carleton Hospital

Ottawa, Ontario, K2H 8P4, Canada

Location

Related Publications (2)

• McIntyre L, Fergusson D, McArdle T, English S, Cook DJ, Fox-Robichaud AE, Martin C, Marshall J, Pugliese M, Menon K, Thavorn K, Graham ID, Hawken S, Iyengar A, Kyeremanteng K, Saginur R, Seely AJE, Stiell IG, Bainbridge D, Weijer C, Taljaard M; Canadian Critical Care Trials Group. A Crossover Trial of Hospital-Wide Lactated Ringer's Solution versus Normal Saline. N Engl J Med. 2025 Aug 14;393(7):660-670. doi: 10.1056/NEJMoa2416761. Epub 2025 Jun 12.

  PMID: 40503714 DERIVED

• Shaw JF, Ouyang Y, Fergusson DA, McArdle T, Martin C, Cook D, Graham ID, Hawken S, McCartney CJL, Menon K, Saginur R, Seely A, Stiell I, Fox-Robichaud A, English S, Marshall J, Thavorn K, Taljaard M, McIntyre LA; Canadian Critical Care Trials Group. A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer's Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial. JMIR Res Protoc. 2023 Oct 6;12:e51783. doi: 10.2196/51783.

  PMID: 37801356 DERIVED

MeSH Terms

Conditions

Hypovolemia

Interventions

Ringer's Lactate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lauralyn McIntyre, MS MHSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Cross Over

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: August 14, 2020
• Study Start: August 15, 2016
• Primary Completion: June 13, 2020
• Study Completion: June 13, 2020
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)