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NCT05349370 Clinical Trial

Lactate Kinetics in Septic Shock

Sepsis Clinical Trial

— LKISS  

Official title:
Lactate Kinetics in Patients Treated for Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05349370
Other study ID # K 2022-4066
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Karolinska University Hospital
Contact Jonathan Grip, MD, PhD
Phone +46736230906
Email jonathan.grip@regionstockholm.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 รก 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (4)
Lead Sponsor Collaborator
Karolinska University Hospital European Society of Intensive Care Medicine, Region Stockholm, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Whole body rate of appearance of lactate The total amount of lactate produced per unit of time 2 hours
Secondary Clearance of lactate Amount of plasma that is cleared from lactate per unit of time 2 hours
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