"Point of Care" Ultrasound and Renal Colic

NCT ID: NCT04169555

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2020-07-31

Brief Summary

The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.

Currently, two imaging techniques are recommended during an episode of renal colic:

1. Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h

2. The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.

The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.

In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.

The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.

Conditions

Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrasound

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

The emergency physician will perform a "point of care" ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow

Standard care

Group Type: OTHER

Standard care

Intervention Type: OTHER

Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.

Interventions

Ultrasound

The emergency physician will perform a "point of care" ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow

Intervention Type: PROCEDURE

Standard care

Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients admitted in ER for suspicion of simple renal colic
• Signed informed consent

Exclusion Criteria

• protected adults (tutorship or guardianship)
• fever ≥ 38.5°C
• chronic endstage kidney failure (Glomerular filtration rate < 30%)
• Solitary kidney
• Urinary tract catheter or percutaneous nephrectomy
• Pregnancy
• traumatic back pain
• Renal colic diagnosis in the past three months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duga Hervé, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

GHICL

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie Lansiaux, MD, PhD

Role: CONTACT

lansiaux.amelie@ghicl.net

0320225269 ext. 0033

Jean-Jacques Vitagliano

Role: CONTACT

vitagliano.jean-jacques@ghicl.net

0320225751 ext. 0033

Facility Contacts

Hervé Duga, MD

Role: primary

duga.herve@ghicl.net

03 20 87 45 09 ext. 0033

Other Identifiers

RC-P0072

Identifier Type: -

Identifier Source: org_study_id