Lactate Metabolism in the Hypoperfused Critically Ill

Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis

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

Study Overview

• Status: Recruiting
• Conditions: Metabolism; Hypoperfusion; Metabolic Acidosis; Lactate; Metabolomics
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Henrik Wolsted, MD; Phone Number: +4521494485; Email: henrik.wolsted01@regionh.dk
• Study Contact Backup: Name: Jesper H Kilbak, Stud. scient.; Phone Number: +4531957973; Email: qzt497@alumni.ku.dk

Study Locations

• Denmark
  • Hovedstaden
    • Hvidovre, Hovedstaden, Denmark, 2650
      • Recruiting
      • Hvidovre University Hospital
      • Contact: Henrik Wolsted, MD; Phone Number: +4521494485; Email: henrik.wolsted01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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.
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).
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).
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).

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2022
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (ACTUAL): October 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Metabolomics; Lactate; Metabolism; Metabolic Acidosis; Hypoperfusion
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: LacMeta

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No