Lactate Kinetics in Septic Shock

Not Applicable

Recruiting

• Conditions: Sepsis; Septic Shock
• Interventions: Other: Isotopically labeled lactate

• Registration Number: NCT05349370
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-12-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-03-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Isotopically labeled lactate	All patients receive the same intervention/sampling protocol

Primary Outcome Measures

Name	Time	Method
Whole body rate of appearance of lactate	2 hours	The total amount of lactate produced per unit of time

Secondary Outcome Measures

Name	Time	Method
Clearance of lactate	2 hours	Amount of plasma that is cleared from lactate per unit of time

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden