Mesenteric IschemiaNCT04671979
Serum Lactate in Acute Mesenteric Ischemia
An observational study of Mesenteric Ischemia, run by Universidad del Rosario at 1 site in Colombia.
Trial summary
Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenteric Ischemia
- What is being tested?
- Lactate Dehydrogenase
- How many people
- 74 participants
- Where
- 1 siteColombia
- Study dates
- 2 May 2017to 30 Jun 2020
- How long will I take part?
- 30 Days
- 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: Seventy-four cases were identified that met the study's criteria. The patients' average age was 73.5 (SD, 10.7) years, and 44 (60%) were men. The mean body mass index was 25 (SD, 2.9) kg/m2. Fifteen (20%) of the patients presented non-occlusive acute mesenteric ischemia.
Who may be able to join
- Older than 18 years of age
- Required urgent laparotomy with a postoperative diagnosis of acute mesenteric ischemia
- Attended the private academic hospital, between 2012 and 2018
- Had a registered serum lactate dehydrogenase at admission
Who cannot join
- Secondary causes of AMI
- Chronic intestinal ischemic
- Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactate Dehydrogenase, Bowel Necrosis and Mortality in Acute Mesenteric Ischemia: Retrospective Cross-Sectional
Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization.
Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.
- Conditions
- Mesenteric Ischemia
- Being tested
- Lactate Dehydrogenase
- Keywords
- Biomarker, L-Lactate, Mortality
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate DehydrogenaseDiagnostic test
All the patients that arrived at the hospital with symptoms of mesenteric ischemia, had a registered lactate dehydrogenase. We compared the value with the patient's outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lactate in mmol/l
Measured: 30 days
Bowel necrosis length in cm
Measured: 30 days
Percentage of patients that died between 30 postsurgical days, %
Measured: 30 days
Secondary outcomes (1)
Cut value of lactate levels as a predictor of mortality, in mmol/l
A receiver operating characteristics curve
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 May 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Universidad del Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Isaza Restrepo, Universidad del Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671979
- Sponsor's protocol ID
- DVO005-1-431-CEI969
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't plan to share de IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Dehydrogenase, Bowel Necrosis and Mortality in Acute Mesenteric Ischemia: Retrospective Cross-Sectional
- ClinicalTrials.gov ID
- NCT04671979
- Acronym / sponsor ID
- DVO005-1-431-CEI969
- Conditions
- Mesenteric Ischemia
- Keywords
- Biomarker, L-Lactate, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidad del RosarioUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization.
Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy-four cases were identified that met the study's criteria. The patients' average age was 73.5 (SD, 10.7) years, and 44 (60%) were men. The mean body mass index was 25 (SD, 2.9) kg/m2. Fifteen (20%) of the patients presented non-occlusive acute mesenteric ischemia.
Key inclusion criteria (4 listed)
- Older than 18 years of age
- Required urgent laparotomy with a postoperative diagnosis of acute mesenteric ischemia
- Attended the private academic hospital, between 2012 and 2018
- Had a registered serum lactate dehydrogenase at admission
Key exclusion criteria (3 listed)
- Secondary causes of AMI
- Chronic intestinal ischemic
- Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactate DehydrogenaseAll the patients that arrived at the hospital with symptoms of mesenteric ischemia, had a registered lactate dehydrogenase. We compared the value with the patient's outcomes. | Diagnostic test | – |
Primary outcome
Serum Lactate in mmol/l
Time frame: 30 days
Bowel necrosis length in cm
Time frame: 30 days
Percentage of patients that died between 30 postsurgical days, %
Time frame: 30 days
1 secondary outcome
Cut value of lactate levels as a predictor of mortality, in mmol/l
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No. We don't plan to share de IPD.
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Active, not recruiting
ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery
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RecruitingObservational study
Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mesenteric Ischemia, run by Universidad del Rosario at 1 site in Colombia.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Dec 2020. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Lactate in mmol/l (time frame: 30 days). The study lists 3 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 17 Dec 2020.