Lactate Metabolism in the Hypoperfused Critically Ill

Recruiting

• Conditions: Lactate; Metabolic Acidosis; Hypoperfusion; Metabolism; Metabolomics
• Interventions: Other: Blood and urine test

• Registration Number: NCT05582824
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study Start: 2022-09-15
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-17
• Last Update Posted: 2022-10-17
• Primary Completion: 2022-11
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main group	Blood and urine test	All patients included

Primary Outcome Measures

Name	Time	Method
Laktate levels in blood	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).	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.

Secondary Outcome Measures

Name	Time	Method
Metabolomics using High Pressure Liquid Cromotografy (HPLC) and Mass Spectrometry (MS)	Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).	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.
Pyruvate and hydroxybuterate concentration in blood and urine	Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).	Concentration of pyruvate and hydroxybutyrate from blood- and urinsamples are analysed by assays kits on the same occation as metabolomics (HPLC and MS)
Near-infrared spectroscopy (NIRS)	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).	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.
Mortality	Admission time ranges up to 6 months.	Whether or not the patient survived the illness that coursed the admission to the ICU and hospital.
Peripheral perfusion index (PPI)	Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).	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.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Hovedstaden, Denmark