Crystalloid FLUID Choices for Resuscitation of Hospital Patients

NCT02721485 | Completed

• 1 other identifier: 20150619-01H
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 4

Brief Summary

Salt fluids are used extensively for acutely ill patients who are admitted to hospital. Two salt fluids commonly used are Normal Saline and Ringer's Lactate. Both are used to rehydrate patients, restore fluid volume and help stabilize blood pressure and failing organs. Both salt fluids 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). Recent data suggest that salt fluids containing less chloride like the Ringer's Lactate, cause less acid in the blood, less kidney failure, and less death. However, the studies to date are small and weak in their design and it is possible that there are no important differences that affect patients. Hence, the research team will conduct a robust pragmatic clinical trial where several academic and community hospitals will be randomized to use either Ringer's Lactate only or Normal Saline only for a period of three months. The trial will yield high quality and robust data to determine if Ringers Lactate reduces death and re-admissions to hospital. Before embarking on this large-scale trial, it is important to conduct a smaller (pilot) trial to evaluate if the larger trial will be feasible and not too costly. In this small trial involving no less than 4 hospitals, the investigators will determine how well the fluid interventions are adhered to in each hospital, record how long it takes to receive approval from research ethics boards and be ready to start the study. The investigators will also record challenges and develop solutions related to the operations of the trial, and describe important clinical and outcome data essential for the design and planning of the large trial.

Conditions

Fluid Therapy

Keywords

Ringer's Lactate; Normal Saline; resuscitation fluids; hypovolemia

Outcome Measures

Primary Outcomes (3)

• Feasibility: adherence to protocol

  Compliance defined as at least 80% of the prescribed study fluid being administered in the participating hospitals over the 2, 3-month study periods.

  Up to six months

• Feasibility: time to research ethics board approval

  Compliance defined as taking no longer than 3 months to achieve

  Up to three months

• Feasibility: readiness to initiate protocol

  Compliance defined as taking no longer than 3 months after ethics approval

  Up to three months

Study Arms (2)

Normal Saline

OTHER

Half of the hospitals will be allocated to start the 90-day test period using Normal Saline administered as 500 or 1000 ml boluses or infusions as specified by the treating physicians. After a 1 week run out, half of participating hospitals will have up to 2 weeks to switch out stock then will be crossed over to using Ringer's Lactate following a 1 week run in as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the final 90-day test period.

Other: Ringer's Lactate

Ringer's Lactate

OTHER

Half of the hospitals will be allocated to start the 90-day test period using Ringer's Lactate administered as 500 or 1000 ml boluses or infusions as specified by the treating physicians. After a 1 week run out, half of participating hospitals will have up to 2 weeks to switch out stock then will be crossed over to using Normal Saline following a 1 week run in as 500 or 1000 ml boluses or infusions as specified by the treating physicians in for the final 90-day test period.

Other: Normal Saline

Interventions

Ringer's Lactate OTHER

After a 1 week run in half of participating hospitals will be crossed over to using Ringer's Lactate as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the second 90-day test period.

Normal Saline

Normal Saline OTHER

After a 1 week run in half of participating hospitals will be crossed over to using Normal Saline as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the final 90-day test period.

Ringer's Lactate

Eligibility Criteria

• Age: 30 Days - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the participating hospitals for the first time in the last 90 days (index admission) over the duration of the study period.

You may not qualify if:

• Neonates (\< 30 days)
• Physicians may also opt out of the use of the allocated study fluid for individual patients if there is a strong preference to do so.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (4)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa Hospital Civic Campus

Ottawa, Ontario, 1053 Carling Ave, Canada

Location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Queensway Carleton Hosptial

Ottawa, Ontario, K2H 8P4, Canada

Location

Related Publications (2)

• McIntyre LA, Fergusson DA, McArdle T, Fox-Robichaud A, English SW, Martin C, Marshall J, Cook DJ, Graham ID, Hawken S, McCartney C, Menon K, Saginur R, Seely A, Stiell I, Thavorn K, Weijer C, Iyengar A, Muscedere J, Forster AJ, Taljaard M; Canadian Critical Care Trials Group. FLUID trial: a hospital-wide open-label cluster cross-over pragmatic comparative effectiveness randomised pilot trial comparing normal saline to Ringer's lactate. BMJ Open. 2023 Feb 3;13(2):e067142. doi: 10.1136/bmjopen-2022-067142.

  PMID: 36737087 DERIVED

• McIntyre L, Taljaard M, McArdle T, Fox-Robichaud A, English SW, Martin C, Marshall J, Menon K, Muscedere J, Cook DJ, Weijer C, Saginur R, Maybee A, Iyengar A, Forster A, Graham ID, Hawken S, McCartney C, Seely AJ, Stiell IG, Thavorn K, Fergusson DA. FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial. BMJ Open. 2018 Aug 23;8(8):e022780. doi: 10.1136/bmjopen-2018-022780.

  PMID: 30139908 DERIVED

MeSH Terms

Conditions

Hypovolemia

Interventions

Ringer's Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lauralyn McIntyre, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 29, 2016
• Study Start: July 1, 2016
• Primary Completion: January 13, 2018
• Study Completion: January 13, 2018
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)