Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue

NCT03015233 | Unknown

• 1 other identifier: AFERSAU-2016-01
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal pain is one of the most common reasons for consultation in Emergency Departments (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The actual gold standard for diagnosis is computed tomography (CT). However with this procedure there is high radiation exposure and a risk factor of radiation-induced cancers, therefore alternative diagnostic techniques should be considered. The aim of this study is to evaluate the performance of measuring venous lactate in patients presenting with acute abdominal pain in ED. In this single-center, prospective, non-interventional study, the diagnostic accuracy of venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here is that venous lactatemia is a positive predictive factor of surgical emergencies in patients with acute abdominal pain.

Conditions

Abdomen, Acute; Renal Colic

Keywords

Lactate; Acute Abdominal Pain; Acute Abdomen; Strong Ion Gap; Renal Colic; Emergency Department; Emergency; Surgery; Stewart

Outcome Measures

Primary Outcomes (2)

• Venous lactate value

  At admission of patient in the ED (Day 1) between arrival and up to one hour later

• Surgical issue

  The occurence/or not of a surgical outcome in patients with acute abdomen, during the seven days following the ED visit, will be assessed by consulting patients' medical records or by calling them at D7.

  From Day 1 (D1) to Day 7 (D7)

Secondary Outcomes (1)

• Strong ion gap as Stewart approach

  At admission of patient in the ED (Day 1) between arrival and up to one hour later

Eligibility Criteria

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

Study Population

Patients presenting abdominal pain since seven days or less, older than 18 years old, and who need a blood analysis to perform diagnosis after physician's clinical evaluation.

You may qualify if:

• Patients over 18 years old
• Patient presenting acute abdominal pain since 7 days or less
• Need of blood sample confirmed by physician
• Affiliation to french social security system
• Informed Consent

You may not qualify if:

• Post traumatic abdominal pain / occurrence of abdominal trauma in the 7 days before ED visit
• Patients with cirrhosis classified as Child-Pugh C

Sponsors & Collaborators

• Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences: lead

Study Sites (1)

Nice University Hospital - Pasteur 2

Nice, France, 06000, France

RECRUITING

MeSH Terms

Conditions

Abdomen, Acute; Renal Colic; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Julie CONTENTI, MD

  Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

  STUDY CHAIR

Central Study Contacts

Pauline S SIVRY, MD

CONTACT

+33492038687; sivry.p@chu-nice.fr

Jocelyn F RAPP, MS

CONTACT

+33492038535; rapp.j@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: January 10, 2017
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

FR (1)