Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 23, 2016
First Posted Date January 10, 2017
Last Update Posted Date January 10, 2017
Study Start Date June 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2017)
  • 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 Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 6, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue
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 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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Abdomen, Acute
  • Renal Colic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 6, 2017)
660
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03015233
Other Study ID Numbers AFERSAU-2016-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Study Sponsor Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Collaborators Not Provided
Investigators
Study Chair: Julie CONTENTI, MD Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
PRS Account Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Verification Date January 2017