Acute Abdominal Pain Clinical Trial
Official title:
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03281031 -
MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women
|
N/A |