NCT04671979

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

December 3, 2020

Last Update Submit

December 11, 2020

Conditions

Keywords

BiomarkerL-LactateMortality

Outcome Measures

Primary Outcomes (3)

  • Serum Lactate in mmol/l

    30 days

  • Bowel necrosis length in cm

    30 days

  • Percentage of patients that died between 30 postsurgical days, %

    30 days

Secondary Outcomes (1)

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

    30 days

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andres Isaza Restrepo

Bogotá, Cundinamarca, 111221, Colombia

Location

MeSH Terms

Conditions

Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeritoneal DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 17, 2020

Study Start

May 2, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

We don't plan to share de IPD.

Locations