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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05582824
Other study ID # LacMeta
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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).
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