Lactate Metabolism in the Hypoperfused Critically Ill

NCT ID: NCT05582824

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-01-31

Brief Summary

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Investigating lactate metabolism in critically ill patients whom are hypoperfused by preforming metabolomics via liquid chromatography-mass spectrometry.

Detailed Description

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Lactate concentration is well known to be directly correlated with risk of death during admission to intensive care. However, lactate by itself is not considered toxic. The study is observational. The breakdown of lactate is being investigated by collecting blood- and urinsamples from patients with hyperlactatemia as a result of hypoperfusion. Levels of lactate, and known as well as unknown metabolites will be identified and quantified by metabolomics. Metabolomics is performed using a combination of liquid chromatography and mass spectrometry. Data will be analysed via statistical analysis to investigate corelations between lactate, a given metabolite and hard outcome such as mortality. And thereby lay the groundwork for potential further research regarding specific lactate-metabolites.

Conditions

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Lactate Metabolism Hypoperfusion Metabolomics Metabolic Acidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main group

All patients included

Blood and urine test

Intervention Type OTHER

Daily blood and urine samples

Interventions

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Blood and urine test

Daily blood and urine samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with sepsis/septic shock or severe heart failure.
* Clinical and paraclinical signs of hypoperfusion in relation to abovementioned diagnosis.
* Metabolic acidosis with s-lactate equal-to-or-above 4 mmol/l.
* Incapacitated

Exclusion Criteria

* Only regional hypoperfusion such as a leg.
* Receiving intravenous lactate as part of treatment.
* Going in to dialysis. The exclusion is only during dialysis treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hvidovre University Hospital

Hvidovre, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Henrik Wolsted, MD

Role: CONTACT

+4521494485

Jesper H Kilbak, Stud. scient.

Role: CONTACT

+4531957973

Facility Contacts

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Henrik Wolsted, MD

Role: primary

+4521494485

Other Identifiers

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LacMeta

Identifier Type: -

Identifier Source: org_study_id

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