Renal Colic Fast Track Pathway in the Emergency Department.

NCT ID: NCT03706404

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Point-of-care Testing and Ultrasound pathway

Group Type EXPERIMENTAL

Point-of-Care ultrasound and testing

Intervention Type DIAGNOSTIC_TEST

Point-of-Care ultrasound + Point-of-Care blood gas testing

Classical pathway

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Point-of-Care ultrasound and testing

Point-of-Care ultrasound + Point-of-Care blood gas testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

OTHER

Sponsor Role lead

Responsible Party

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Yale Tung Chen

Attending physician, Fellow director of the ultrasound division in the emergency department, principal investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33496396 (View on PubMed)

Other Identifiers

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URGG/HULP_2018_03

Identifier Type: -

Identifier Source: org_study_id

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