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Renal Colic Fast Track Pathway in the Emergency Department.

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ClinicalTrials.gov Identifier: NCT03706404
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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.

Condition or disease Intervention/treatment Phase
Renal Colic Diagnostic Test: Point-of-Care ultrasound and testing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Point-of-care Testing and Ultrasound pathway Diagnostic Test: Point-of-Care ultrasound and testing
Point-of-Care ultrasound + Point-of-Care blood gas testing

No Intervention: Classical pathway



Primary Outcome Measures :
  1. Length of stay in the Emergency Department [ Time Frame: 24 hours ]
  2. Adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Number of conclusive exams in the Point-of-Care intervention arm. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03706404


Contacts
Contact: Yale Tung Chen, MD +34 917 27 70 00 yale.tung@salud.madrid.org

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Yale Tung Chen, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Responsible Party: Yale Tung Chen, Attending physician, Fellow director of the ultrasound division in the emergency department, principal investigator., Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier: NCT03706404     History of Changes
Other Study ID Numbers: URGG/HULP_2018_03
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
Renal Colic
Point-of-Care ultrasound
Point-of-Care testing

Additional relevant MeSH terms:
Emergencies
Colic
Renal Colic
Disease Attributes
Pathologic Processes
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms