Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue

Acute Abdominal Pain in Emergency Department: Evaluation of Venous LACtate Value and Strong Ion GAp According to the Stewart Approach as Predictive Factors of Surgical Issue

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03015233

Acronym

GALAC

Enrollment

660

Registered

2017-01-10

Start date

2016-06-30

Completion date

Unknown

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomen, Acute, Renal Colic

Keywords

Lactate, Acute Abdominal Pain, Acute Abdomen, Strong Ion Gap, Renal Colic, Emergency Department, Emergency, Surgery, Stewart

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Venous lactate value	At admission of patient in the ED (Day 1) between arrival and up to one hour later	—
Surgical issue	From Day 1 (D1) to Day 7 (D7)	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.

Secondary

Measure	Time frame	Description
Strong ion gap as Stewart approach	At admission of patient in the ED (Day 1) between arrival and up to one hour later	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.

Countries

France

Contacts

Primary ContactPauline S SIVRY, MD

sivry.p@chu-nice.fr+33492038687

Backup ContactJocelyn F RAPP, MS

rapp.j@chu-nice.fr+33492038535

Outcome results