Serum Lactate in Acute Mesenteric Ischemia

December 11, 2020 updated by: Andrés Isaza Restrepo, Universidad del Rosario

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111221
        • Andres Isaza Restrepo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Lactate in mmol/l
Time Frame: 30 days
30 days
Bowel necrosis length in cm
Time Frame: 30 days
30 days
Percentage of patients that died between 30 postsurgical days, %
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cut value of lactate levels as a predictor of mortality, in mmol/l
Time Frame: 30 days
A receiver operating characteristics curve
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Rosario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVO005-1-431-CEI969

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We don't plan to share de IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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