"Point of Care" Ultrasound and Renal Colic

NCT04169555 | Unknown

• 1 other identifier: RC-P0072
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 1.Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
2. 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.

Conditions

Renal Colic

Keywords

ultrasound; renal colic; emergency room; point of care

Outcome Measures

Primary Outcomes (1)

• Time between admission and discharge from the emergency room

  Day one

Secondary Outcomes (3)

• Patients satisfaction scale

  An average of 24 hours

• Physician satisfaction scale

  9 months

• Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities

  9 months

Study Arms (2)

Ultrasound

EXPERIMENTAL

Procedure: Ultrasound

Standard care

OTHER

Other: Standard care

Interventions

Ultrasound 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

Ultrasound

Standard care 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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

GHICL

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Renal Colic; Emergencies

Interventions

High-Energy Shock Waves; Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Duga Hervé, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

0320225269; lansiaux.amelie@ghicl.net

Jean-Jacques Vitagliano

CONTACT

0320225751; vitagliano.jean-jacques@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 20, 2019
• Study Start: October 7, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)