Biomarkers in Acute Abdomen (BIOMAB)

Biomarkers in Acute Abdomen (BIOMAB)

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.

Study Overview

• Status: Completed
• Conditions: Acute Abdominal Pain
• Intervention / Treatment: Other: No intervention as observational study

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service d'Accueil des Urgences, CHU Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients presenting to the ED with acute abdomen

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Abdominal Pain; patients presenting to the ED with acute abdomen	Other: No intervention as observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency	15 days

Collaborators and Investigators

• Sponsor: Pitié-Salpêtrière Hospital
• Collaborators: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
• Investigators: Principal Investigator: Pierre Hausfater, MD, Pr, Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (ESTIMATE): March 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pain; acute abdomen; stress biomarker
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Abdomen, Acute
• Other Study ID Numbers: BIOMAB