Renal Colic Fast Track Pathway in the Emergency Department.
Randomised Controlled Trial to Assess a Renal Colic Fast Track Pathway in the Emergency Department Using Point-of-care Ultrasound and Point-of-care Testing.
1 other identifier
interventional
128
1 country
1
Brief Summary
Validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the Point-of-Care Testing (POCT) and Point-of-Care ultrasound (POCUS) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedSeptember 24, 2019
September 1, 2019
12 months
October 11, 2018
September 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Length of stay in the Emergency Department
24 hours
Adverse events
30 days
Secondary Outcomes (1)
Number of conclusive exams in the Point-of-Care intervention arm.
24 hours
Study Arms (2)
Point-of-care Testing and Ultrasound pathway
EXPERIMENTALClassical pathway
NO INTERVENTIONInterventions
Point-of-Care ultrasound + Point-of-Care blood gas testing
Eligibility Criteria
You may qualify if:
- First renal colic episode
- Need of analgesia
- Oral tolerance
You may not qualify if:
- Hemodynamic instability
- Fever
- Anuria
- Abdominal trauma
- Chronic renal failure
- Active oncologic disease
- Kidney transplant or monorenal patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, 28046, Spain
Related Publications (1)
Tung Chen Y, Rodriguez Fuertes P, Oliver Saez P, Villen Villegas T, Buno Soto A, Fernandez Calle P, Carballo Cardona C, Cobo Mora J, Jaen Canadas M, Yan Tong H, M Borobia A. Efficacy of a fast-track pathway for managing uncomplicated renal or ureteral colic in a hospital emergency department: the STONE randomized clinical trial of Sonography and Testing of a Nephrolithiasis Episode. Emergencias. 2021 Feb;33(1):23-28. English, Spanish.
PMID: 33496396DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician, Fellow director of the ultrasound division in the emergency department, principal investigator.
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 16, 2018
Study Start
October 1, 2018
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
September 24, 2019
Record last verified: 2019-09