NCT05582824

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 17, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 13, 2022

Last Update Submit

October 12, 2022

Conditions

Keywords

LactateMetabolismHypoperfusionMetabolomicsMetabolic Acidosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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).

  • Mortality

    Admission time ranges up to 6 months.

  • 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).

  • Near-infrared spectroscopy (NIRS)

    Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).

  • Peripheral perfusion index (PPI)

    Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).

Study Arms (1)

Main group

All patients included

Other: Blood and urine test

Interventions

Daily blood and urine samples

Main group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Only regional hypoperfusion such as a leg.
  • Receiving intravenous lactate as part of treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Acidosis

Interventions

Blood Specimen CollectionUrinalysis

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesClinical Chemistry TestsDiagnostic Techniques, Urological

Central Study Contacts

Jesper H Kilbak, Stud. scient.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

October 17, 2022

Study Start

September 15, 2022

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

October 17, 2022

Record last verified: 2022-09

Locations