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Completed

NCT Number: NCT04671979

Serum Lactate in Acute Mesenteric Ischemia

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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Key information

Conditions

Mesenteric Ischemia Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Peritoneal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andres Isaza Restrepo

Bogotá, Cundinamarca, 111221, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactate dehydrogenase

Diagnostic 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.

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

    Time frame: 30 days

    A receiver operating characteristics curve

Sponsors and collaborators

Lead sponsor

Universidad del Rosario

Other

Registry information

Official study title

Lactate Dehydrogenase, Bowel Necrosis and Mortality in Acute Mesenteric Ischemia: Retrospective Cross-Sectional

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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