LactateNCT05582824
Lactate Metabolism in the Hypoperfused Critically Ill
An observational study of Lactate and Metabolism, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Investigating lactate metabolism in critically ill patients whom are hypoperfused by preforming metabolomics via liquid chromatography-mass spectrometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactate, Metabolism, Hypoperfusion
- What is being tested?
- Blood and urine test
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, Capital Region, 2650
Henrik Wolsted, MD, +4521494485, henrik.wolsted01@regionh.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Lactate, Metabolism, Hypoperfusion, Metabolomics, Metabolic Acidosis
- Being tested
- Blood and urine test
- Keywords
- Lactate, Metabolism, Hypoperfusion, Metabolomics, Metabolic Acidosis
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine testOther
Daily blood and urine samples
| Study group | Role | What they receive |
|---|---|---|
| Main group | All patients included Receives: Other: Blood and urine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Sep 2022
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactateStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582824
- Sponsor's protocol ID
- LacMeta
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis
- ClinicalTrials.gov ID
- NCT05582824
- Acronym / sponsor ID
- LacMeta
- Conditions
- Lactate, Metabolism, Hypoperfusion, Metabolomics, Metabolic Acidosis
- Keywords
- Lactate, Metabolism, Hypoperfusion, Metabolomics, Metabolic Acidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Other: Blood and urine testAll patients included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine testDaily blood and urine samples | Other | Main group |
Primary outcome
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.
5 secondary outcomes
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).
Mortality
Time frame: 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).
Near-infrared spectroscopy (NIRS)
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactate and Metabolism, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Wolsted, MD (+4521494485, henrik.wolsted01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laktate levels in blood (time frame: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.