Lactate Metabolism in the Hypoperfused Critically Ill

Metabolism Clinical Trial

Official title:

Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582824
• Other study ID #: LacMeta
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: January 2023

Study information

• Verified date: September 2022
• Source: University of Copenhagen
• Contact: Henrik Wolsted, MD
• Phone: +4521494485
• Email: henrik.wolsted01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acidosis
• Hypoperfusion
• Lactate
• Metabolic Acidosis
• Metabolism
• Metabolomics

Intervention

Other:
• Blood and urine test
Daily blood and urine samples

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laktate levels in blood	Levels of lactate in the blood in relation to the key metabolites (secondary outcomes). Patients included will be testet daily during admission to intensive care whilst lactate is above 2 mmol/l and one more day while laktat is below.	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Secondary	Metabolomics using High Pressure Liquid Cromotografy (HPLC) and Mass Spectrometry (MS)	Frozen samples collectet during inclusion of patients are analyzed using HPLC and MS which yields results that can later be examined. These results indicate which metabolites are related to, and derived from, lactate. Analasys of blood and urine samples will be done at two seperate days.	Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).
Secondary	Mortality	Whether or not the patient survived the illness that coursed the admission to the ICU and hospital.	Admission time ranges up to 6 months.
Secondary	Pyruvate and hydroxybuterate concentration in blood and urine	Concentration of pyruvate and hydroxybutyrate from blood- and urinsamples are analysed by assays kits on the same occation as metabolomics (HPLC and MS)	Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).
Secondary	Near-infrared spectroscopy (NIRS)	In this case, NIRS consists of two electrodes placed above the eyebrow and on the shoulder. Near-infrared light is sent out by the electrodes to meassure the collour for the blood. Thereby providing information about the oxygen saturation of haemoglobin within the microcirculation.	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Secondary	Peripheral perfusion index (PPI)	PPI is a small clamp around the finger which, like NIRS, uses lightwaves. It measures the ratio of the pulsing blood to non-pulsing blood flow in your finger and is used to indicate the strength of blood flow to your finger. Thereby estimating the microcirculation of the patients.	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).