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

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ClinicalTrials.gov Identifier: NCT03015233
Recruitment Status : Unknown
Verified January 2017 by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences.
Recruitment status was:  Recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

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.


Condition or disease
Abdomen, Acute Renal Colic

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.

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Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : June 2016
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain




Primary Outcome Measures :
  1. Venous lactate value [ Time Frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later ]
  2. 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.


Secondary Outcome Measures :
  1. 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 ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015233


Contacts
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Contact: Pauline S SIVRY, MD +33492038687 ext +33 sivry.p@chu-nice.fr
Contact: Jocelyn F RAPP, MS +33492038535 ext +33 rapp.j@chu-nice.fr

Locations
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France
Nice University Hospital - Pasteur 2 Recruiting
Nice, France, 06000
Contact: Pauline S SIVRY, MD    +33492038687 ext +33    sivry.p@chu-nice.fr   
Contact: Jocelyn F RAPP, MS    +33492038535 ext +33    rapp.j@chu-nice.fr   
Principal Investigator: Pauline S SIVRY, MD         
Sub-Investigator: Julie CONTENTI, MD         
Sponsors and Collaborators
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Investigators
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Study Chair: Julie CONTENTI, MD Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
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Responsible Party: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
ClinicalTrials.gov Identifier: NCT03015233    
Other Study ID Numbers: AFERSAU-2016-01
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences:
Lactate
Acute Abdominal Pain
Acute Abdomen
Strong Ion Gap
Renal Colic
Emergency Department
Emergency
Surgery
Stewart
Additional relevant MeSH terms:
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Abdominal Pain
Renal Colic
Abdomen, Acute
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive