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Recruiting NCT05349370

Lactate Kinetics in Septic Shock

No phase Interventional Sepsis Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isotopically labeled lactate.
Who it may be relevant to
Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Lactate Kinetics in Patients Treated for Septic Shock

Overview

Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

Detailed description

Adult septic patients admitted to the Intensive Care Unit (ICU) or Intermediary Medical Unit in Karolinska University Hospital will be recruited within 72 hours from start of symptoms.

Other than fulfilling the definition for sepsis-3, patients need to be equipped with an arterial catheter to be eligible for inclusion. After informed consent (from next of kin when applicable) baseline blood samples are drawn from existing catheter and the subject is given a bolus dose of 20umol/kg 13C-labeled lactate in 20 ml isotonic saline. After this a total of 14 blood samples á 2 ml is drawn in the following 120 minutes. All blood samples are centrifuged and stored in -800 C until analysis. After all subjects have been included sampled are thawed and analyzed for content of endogenous and labeled lactate. Through analysis between their relationship the lactate production and consumption can be quantified.

Interventions

  • Other Isotopically labeled lactate
    A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn

Primary outcome measures

  • Whole body rate of appearance of lactate [Time frame: 2 hours]
Secondary outcome measures (1)
  • Clearance of lactate [Time frame: 2 hours]

Eligibility criteria

Inclusion criteria

  • Sepsis
  • Age >17 years
  • Arterial catheter
  • Lactate > 2 mmol at any time point prior to inclusion

Exclusion criteria

  • Mitochondrial defect
  • Degenerative muscle disease
  • Terminal liver failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Publications

  • Grip J, Falkenstrom T, Promsin P, Wernerman J, Norberg A, Rooyackers O. Lactate kinetics in ICU patients using a bolus of 13C-labeled lactate. Crit Care. 2020 Feb 10;24(1):46. doi: 10.1186/s13054-020-2753-6. PMID 32041652

Identifiers

NCT: NCT05349370 · K 2022-4066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗