Renal Colic Fast Track Pathway in the Emergency Department.
Primary Purpose
Renal Colic
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Point-of-Care ultrasound and testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Colic focused on measuring Renal Colic, Point-of-Care ultrasound, Point-of-Care testing
Eligibility Criteria
Inclusion Criteria:
- First renal colic episode
- Need of analgesia
- Oral tolerance
Exclusion Criteria:
- Hemodynamic instability
- Fever
- Anuria
- Abdominal trauma
- Chronic renal failure
- Active oncologic disease
- Kidney transplant or monorenal patient
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Point-of-care Testing and Ultrasound pathway
Classical pathway
Arm Description
Outcomes
Primary Outcome Measures
Length of stay in the Emergency Department
Adverse events
Secondary Outcome Measures
Number of conclusive exams in the Point-of-Care intervention arm.
Full Information
NCT ID
NCT03706404
First Posted
October 11, 2018
Last Updated
September 22, 2019
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1. Study Identification
Unique Protocol Identification Number
NCT03706404
Brief Title
Renal Colic Fast Track Pathway in the Emergency Department.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Renal Colic, Point-of-Care ultrasound, Point-of-Care testing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Point-of-care Testing and Ultrasound pathway
Arm Type
Experimental
Arm Title
Classical pathway
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-Care ultrasound and testing
Intervention Description
Point-of-Care ultrasound + Point-of-Care blood gas testing
Primary Outcome Measure Information:
Title
Length of stay in the Emergency Department
Time Frame
24 hours
Title
Adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of conclusive exams in the Point-of-Care intervention arm.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First renal colic episode
Need of analgesia
Oral tolerance
Exclusion Criteria:
Hemodynamic instability
Fever
Anuria
Abdominal trauma
Chronic renal failure
Active oncologic disease
Kidney transplant or monorenal patient
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33496396
Citation
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.
Results Reference
derived
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Renal Colic Fast Track Pathway in the Emergency Department.
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