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

Renal Colic Clinical Trial

— GALAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03015233
• Other study ID #: AFERSAU-2016-01
• Status: Recruiting
• Phase: N/A
• First received: December 23, 2016
• Last updated: January 6, 2017
• Start date: June 2016

Study information

• Verified date: January 2017
• Source: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
• Contact: Pauline S SIVRY, MD
• Phone: +33492038687
• Email: sivry.p[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdomen, Acute
• Abdominal Pain
• Renal Colic

Locations

Country	Name	City	State
France	Nice University Hospital - Pasteur 2	Nice

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous lactate value		At admission of patient in the ED (Day 1) between arrival and up to one hour later	No
Primary	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)	No
Secondary	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	No