search
Back to results

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
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)
search

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

We'll reach out to this number within 24 hrs