Lactate Metabolism in the Hypoperfused Critically Ill

October 12, 2022 updated by: University of Copenhagen

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Hovedstaden
      • Hvidovre, Hovedstaden, Denmark, 2650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Main group
All patients included
Other: Blood and urine test
Daily blood and urine samples

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Laktate levels in blood
Time Frame: 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.
Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolomics using High Pressure Liquid Cromotografy (HPLC) and Mass Spectrometry (MS)
Time Frame: 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.
Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).
Mortality
Time Frame: Admission time ranges up to 6 months.
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
Time Frame: 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)
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)
Time Frame: 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.
Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Peripheral perfusion index (PPI)
Time Frame: 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.
Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings