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NCT Number: NCT05349370

Lactate Kinetics in Septic Shock

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isotopically labeled lactate

Other

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

Primary outcomes

  1. Whole body rate of appearance of lactate

    Time frame: 2 hours

    The total amount of lactate produced per unit of time

Secondary outcomes

  1. Clearance of lactate

    Time frame: 2 hours

    Amount of plasma that is cleared from lactate per unit of time

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Grip, MD, PhD

CONTACT

[email protected]

+46736230906

Olav Rooyackers, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • European Society of Intensive Care Medicine
  • Region Stockholm
  • The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)

Registry information

Official study title

Lactate Kinetics in Patients Treated for Septic Shock

Acronym: LKISS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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