Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03015233
Other study ID # AFERSAU-2016-01
Secondary ID
Status Recruiting
Phase N/A
First received December 23, 2016
Last updated January 6, 2017
Start date June 2016

Study information

Verified date January 2017
Source Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Contact Pauline S SIVRY, MD
Phone +33492038687
Email sivry.p@chu-nice.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Nice University Hospital - Pasteur 2 Nice

Sponsors (1)

Lead Sponsor Collaborator
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous lactate value At admission of patient in the ED (Day 1) between arrival and up to one hour later No
Primary Surgical issue 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. From Day 1 (D1) to Day 7 (D7) No
Secondary Strong ion gap as Stewart approach 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.
At admission of patient in the ED (Day 1) between arrival and up to one hour later No
See also
  Status Clinical Trial Phase
Withdrawn NCT01685658 - Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations Phase 4
Completed NCT01349244 - Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic N/A
Recruiting NCT04169555 - "Point of Care" Ultrasound and Renal Colic N/A
Completed NCT04160520 - Pramipexole and Morphine for Renal Colic Phase 1/Phase 2
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT03865004 - Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment Phase 4
Completed NCT03638921 - 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER Phase 2
Completed NCT03706404 - Renal Colic Fast Track Pathway in the Emergency Department. N/A
Completed NCT03665753 - Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED Early Phase 1
Not yet recruiting NCT05150899 - Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
Recruiting NCT03790514 - Heat Wrap for Renal Colic N/A
Completed NCT00646061 - Pain Control in Renal Colic Phase 1
Completed NCT05653401 - Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. Phase 2
Not yet recruiting NCT02782273 - Morphine Versus Ketorolac in Renal Colic Phase 4
Completed NCT01352676 - Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
Not yet recruiting NCT06412900 - Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
Not yet recruiting NCT06342648 - Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic N/A
Recruiting NCT03137498 - Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department Phase 4
Recruiting NCT01742689 - Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic Phase 3