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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

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.

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

Current Primary Outcome:

• Venous lactate value [ Time Frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later ]
• Surgical issue [ Time Frame: From Day 1 (D1) to Day 7 (D7) ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome: Strong ion gap as Stewart approach [ Time Frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later ]

Original Secondary Outcome: Same as current

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

Dates:
Date Received: December 23, 2016
Date Started: June 2016
Date Completion:
Last Updated: January 6, 2017
Last Verified: January 2017