Abdomen, AcuteGALACNCT03015233
Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue
An observational study of Abdomen, Acute and Renal Colic, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomen, Acute, Renal Colic
- How many people
- 660 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting abdominal pain since seven days or less, older than 18 years old, and who need a blood analysis to perform diagnosis after physician's clinical evaluation.
Who may be able to join
- 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
Who cannot join
- Post traumatic abdominal pain / occurrence of abdominal trauma in the 7 days before ED visit
- Patients with cirrhosis classified as Child-Pugh C
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital - Pasteur 2
Nice, France, 06000
Pauline S SIVRY, MD, +33492038687 ext. +33, sivry.p@chu-nice.fr
Jocelyn F RAPP, MS, +33492038535 ext. +33, rapp.j@chu-nice.fr
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Abdomen, Acute, Renal Colic
- Keywords
- Lactate, Acute Abdominal Pain, Acute Abdomen, Strong Ion Gap, Renal Colic, Emergency Department, Emergency, Surgery, Stewart
- Medical subject headings
- Abdomen, Acute, Renal Colic, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous lactate value
Measured: At admission of patient in the ED (Day 1) between arrival and up to one hour later
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.
Measured: From Day 1 (D1) to Day 7 (D7)
Secondary outcomes (1)
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.
Measured: At admission of patient in the ED (Day 1) between arrival and up to one hour later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie CONTENTI, MD, Study chair, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015233
- Sponsor's protocol ID
- AFERSAU-2016-01
- Acronym
- GALAC
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03015233
- Acronym / sponsor ID
- GALAC / AFERSAU-2016-01
- Conditions
- Abdomen, Acute, Renal Colic
- Keywords
- Lactate, Acute Abdominal Pain, Acute Abdomen, Strong Ion Gap, Renal Colic, Emergency Department, Emergency, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des UrgencesUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting abdominal pain since seven days or less, older than 18 years old, and who need a blood analysis to perform diagnosis after physician's clinical evaluation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Post traumatic abdominal pain / occurrence of abdominal trauma in the 7 days before ED visit
- Patients with cirrhosis classified as Child-Pugh C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous lactate value
Time frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later
Surgical issue
Time frame: 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.
1 secondary outcome
Strong ion gap as Stewart approach
Time frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie CONTENTI, MD study chair
Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdomen, Acute and Renal Colic, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline S SIVRY, MD (+33492038687 ext. +33, sivry.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous lactate value (time frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.