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

Acute Abdominal Pain in Emergency Department: Evaluation of Venous LACtate Value and Strong Ion GAp According to the Stewart Approach as Predictive Factors of Surgical Issue

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.

Study Overview

• Status: Unknown
• Conditions: Renal Colic; Abdomen, Acute

Detailed Description

Abdominal pain is one of the most common reasons for consultation worldwide in Emergency Departments (ED). 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 diagnostic performance of measuring venous lactate in patients with acute abdominal pain in ED.

A single-center, prospective, non-interventional study, will be conducted between June 2016 and January 2017 in the university emergency department of Nice, France. Inclusion criteria are patients aged 18 and over, suffering from abdominal pain for seven days or less and requiring a blood test to help with diagnosis.

The primary outcome is to determine if the value of venous lactate is a predictive factor of emergency surgery in patients with acute abdominal pain.

The secondary outcome is to determine if the "strong ion gap", first defined in "The Stewart Approach", is a predictive factor of emergency surgery in patients with acute abdominal pain.

A blood test will be performed when patients are admitted to the ED. Seven days after being admitted to the ED, patients' outcome will be assessed by consulting patients' medical records or by phone call.

• Study Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

• Study Contact: Name: Pauline S SIVRY, MD; Phone Number: +33 +33492038687; Email: sivry.p@chu-nice.fr
• Study Contact Backup: Name: Jocelyn F RAPP, MS; Phone Number: +33 +33492038535; Email: rapp.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Nice University Hospital - Pasteur 2
    • Contact: Pauline S SIVRY, MD; Phone Number: +33 +33492038687; Email: sivry.p@chu-nice.fr
    • Contact: Jocelyn F RAPP, MS; Phone Number: +33 +33492038535; Email: rapp.j@chu-nice.fr
    • Principal Investigator: Pauline S SIVRY, MD
    • Sub-Investigator: Julie CONTENTI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strong ion gap as Stewart approach	Strong ion gap (SIG) is a calculated value based on the following equation : SIG = (Na+ + K+ + 2xCa2+ + 2xMg2+) - (Cl- - lactate) - HCO3- + albumine x (0.123 x PH - 0.631) + phosphates mesurés x (0.309 x PH - 0.469) All the values are measured on venous samples.	At admission of patient in the ED (Day 1) between arrival and up to one hour later

Collaborators and Investigators

• Sponsor: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
• Investigators: Study Chair: Julie CONTENTI, MD, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Emergency Department; Emergency; Lactate; Renal Colic; Acute Abdominal Pain; Acute Abdomen; Strong Ion Gap; Stewart
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Renal Colic; Abdominal Pain; Abdomen, Acute
• Other Study ID Numbers: AFERSAU-2016-01