Lactate Metabolism in the Hypoperfused Critically Ill

Sponsor

University of Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05582824

Collaborator

Hvidovre University Hospital (Other)

Enrollment

Location

3.5

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lactate Metabolism Hypoperfusion Metabolomics Metabolic Acidosis	Other: Blood and urine test

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis

Actual Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Main group All patients included	Other: Blood and urine test Daily blood and urine samples

Arm

Intervention/Treatment

Main group

All patients included

Other: Blood and urine test

Daily blood and urine samples

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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