Lactate Kinetics in Septic Shock (LKISS)
Lactate Kinetics in Patients Treated for Septic Shock
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan Grip, MD, PhD
- Phone Number: +46736230906
- Email: jonathan.grip@regionstockholm.se
Study Contact Backup
- Name: Olav Rooyackers, Professor
- Email: olav.rooyackers@ki.se
Study Locations
-
-
-
Stockholm, Sweden, 14186
- Recruiting
- Karolinska University Hospital
-
Contact:
- Jonathan Grip, MD, PhD
- Phone Number: +46 73 623 09 06
- Email: jonathan.grip@regionstockholm.se
-
Contact:
- Christian Ahlstedt, MD
- Phone Number: +4670 729 3514
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All patients
All patients receive the same intervention/sampling protocol
|
A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole body rate of appearance of lactate
Time Frame: 2 hours
|
The total amount of lactate produced per unit of time
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clearance of lactate
Time Frame: 2 hours
|
Amount of plasma that is cleared from lactate per unit of time
|
2 hours
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K 2022-4066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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