Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT03015233
Status:
UNKNOWN
Last Update Posted:
2017-01-10
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue
Sponsor:
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALAC
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.
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 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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: