Biomarkers in Acute Abdomen

Biomarkers in Acute Abdomen (BIOMAB)

Sponsors

Lead Sponsor: Pitié-Salpêtrière Hospital

Collaborator: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Source Pitié-Salpêtrière Hospital
Brief Summary

Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.

Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.

Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.

Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.

Study population: 200 patients presenting to the ED with acute abdomen

Eligibility criteria:

- Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years

- Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance

Procedure:

Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.

Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.

Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.

Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.

Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.

Overall Status Completed
Start Date May 2015
Completion Date September 2016
Primary Completion Date September 2016
Study Type Observational
Primary Outcome
Measure Time Frame
diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency 15 days
Enrollment 300
Condition
Intervention

Intervention Type: Other

Intervention Name: No intervention as observational study

Arm Group Label: Acute Abdominal Pain

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- Presentation at ED with acute abdominal pain, aged at least 18 years

Exclusion Criteria:

- No informed consent, pregnancy, homeless, no social assurance

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pierre Hausfater, MD, Pr Principal Investigator Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris
Location
Facility: Service d'Accueil des Urgences, CHU Pitié-Salpêtrière
Location Countries

France

Verification Date

May 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Groupe Hospitalier Pitie-Salpetriere

Investigator Full Name: Hausfater Pierre

Investigator Title: Emergency Department

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Acute Abdominal Pain

Description: patients presenting to the ED with acute abdomen

Acronym BIOMAB
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov