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CompletedNCT04671979Updated Dec 17, 2020

Serum Lactate in Acute Mesenteric Ischemia

An observational study in Mesenteric Ischemia, sponsored by Universidad del Rosario. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Universidad del Rosario · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
74
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Mesenteric Ischemia

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Keywords

  • Biomarker
  • L-Lactate
  • Mortality
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In context

Mesenteric Ischemia

40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.

This study's enrollment of 74 is below the median of 154 across 26 observational studies indexed under Mesenteric Ischemia.

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Lead sponsor

Universidad del Rosario is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Secondary causes of AMI
  • Chronic intestinal ischemic
  • Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
74 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • Diagnostic testLactate Dehydrogenase

    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.

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What researchers measure

Primary outcomes

  1. Serum Lactate in mmol/l

    Time frame: 30 days

  2. Bowel necrosis length in cm

    Time frame: 30 days

  3. Percentage of patients that died between 30 postsurgical days, %

    Time frame: 30 days

Secondary outcomes

  1. Cut value of lactate levels as a predictor of mortality, in mmol/l

    A receiver operating characteristics curve

    Time frame: 30 days

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Study locations

1 site
  • Andres Isaza Restrepo
    Bogotá, Cundinamarca 111221, Colombia
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References and documents

Individual participant data

Plan to share: No — We don't plan to share de IPD.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04671979
Lead sponsor
Universidad del Rosario
Responsible party
Andrés Isaza Restrepo (MD, MSc, Universidad del Rosario) — Principal investigator
First posted
Dec 17, 2020
Start date
May 2, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Dec 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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