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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04671979
Other study ID # DVO005-1-431-CEI969
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2017
Est. completion date June 30, 2020

Study information

Verified date December 2020
Source Universidad del Rosario
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - Secondary causes of AMI - Chronic intestinal ischemic - Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Lactate 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.

Locations

Country Name City State
Colombia Andres Isaza Restrepo Bogotá Cundinamarca

Sponsors (1)

Lead Sponsor Collaborator
Universidad del Rosario

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Lactate in mmol/l 30 days
Primary Bowel necrosis length in cm 30 days
Primary Percentage of patients that died between 30 postsurgical days, % 30 days
Secondary Cut value of lactate levels as a predictor of mortality, in mmol/l A receiver operating characteristics curve 30 days
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