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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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