NCT02399150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

March 23, 2015

Last Update Submit

May 8, 2017

Conditions

Acute Abdominal Pain

Keywords

acute abdomenPainstress biomarker

Outcome Measures

Primary Outcomes (1)

  • diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency

    15 days

Study Arms (1)

Acute Abdominal Pain

patients presenting to the ED with acute abdomen

Other: No intervention as observational study

Interventions

No intervention as observational studyOTHER
Acute Abdominal Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients presenting to the ED with acute abdomen

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Accueil des Urgences, CHU Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Blum CA, Faron M, Paquet AL, Velly L, Brochet C, Tresallet C, Hausfater P. Biomarkers for Detecting Surgical Emergency in Acute Abdomen-A Prospective Observational Study. J Appl Lab Med. 2025 Nov 4;10(6):1537-1551. doi: 10.1093/jalm/jfaf137.

    PMID: 41189107DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA and serum blood, saliva

MeSH Terms

Conditions

Abdomen, AcutePain

Interventions

Observation

Condition Hierarchy (Ancestors)

Abdominal PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Pierre Hausfater, MD, Pr

    Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Department

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

FR(1)