Clinical trial NCT05582824: Lactate Metabolism in the Hypoperfused Critically Ill
Official title: Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lactate
Metabolism
Hypoperfusion
Metabolomics
Metabolic Acidosis
Keywords: Lactate
Metabolism
Hypoperfusion
Metabolomics
Metabolic Acidosis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2022-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A broad spectrum of patients will make up for the population of the study. These are critically ill adults who are admitted to the intensive care unit of Hvidovre Hospital.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Laktate levels in blood
timeFrame: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Secondary outcomes:
measure: Metabolomics using High Pressure Liquid Cromotografy (HPLC) and Mass Spectrometry (MS)
timeFrame: Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).
measure: Mortality
timeFrame: Admission time ranges up to 6 months.
measure: Pyruvate and hydroxybuterate concentration in blood and urine
timeFrame: Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).
measure: Near-infrared spectroscopy (NIRS)
timeFrame: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
measure: Peripheral perfusion index (PPI)
timeFrame: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Hovedstaden
Study officials:
References: