Lactate Kinetics in Septic Shock (LKISS)
Primary Purpose
Sepsis, Septic Shock
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Isotopically labeled lactate
Sponsored by
About this trial
This is an interventional basic science trial for Sepsis
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
Sites / Locations
- Karolinska University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
All patients receive the same intervention/sampling protocol
Outcomes
Primary Outcome Measures
Whole body rate of appearance of lactate
The total amount of lactate produced per unit of time
Secondary Outcome Measures
Clearance of lactate
Amount of plasma that is cleared from lactate per unit of time
Full Information
NCT ID
NCT05349370
First Posted
April 22, 2022
Last Updated
February 2, 2023
Sponsor
Karolinska University Hospital
Collaborators
Region Stockholm, European Society of Intensive Care Medicine, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
1. Study Identification
Unique Protocol Identification Number
NCT05349370
Brief Title
Lactate Kinetics in Septic Shock
Acronym
LKISS
Official Title
Lactate Kinetics in Patients Treated for Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Region Stockholm, European Society of Intensive Care Medicine, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Arm Description
All patients receive the same intervention/sampling protocol
Intervention Type
Other
Intervention Name(s)
Isotopically labeled lactate
Intervention Description
A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn
Primary Outcome Measure Information:
Title
Whole body rate of appearance of lactate
Description
The total amount of lactate produced per unit of time
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Clearance of lactate
Description
Amount of plasma that is cleared from lactate per unit of time
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Grip, MD, PhD
Phone
+46736230906
Email
jonathan.grip@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Olav Rooyackers, Professor
Email
olav.rooyackers@ki.se
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Grip, MD, PhD
Phone
+46 73 623 09 06
Email
jonathan.grip@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Christian Ahlstedt, MD
Phone
+4670 729 3514
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32041652
Citation
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.
Results Reference
result
Learn more about this trial
Lactate Kinetics in Septic Shock
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