SepsisLKISSNCT05349370
Lactate Kinetics in Septic Shock
A study testing Isotopically labeled lactate in people with Sepsis and Septic Shock, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Isotopically labeled lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 28 Dec 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis
- Age >17 years
- Arterial catheter
- Lactate > 2 mmol at any time point prior to inclusion
Who cannot join
- Mitochondrial defect
- Degenerative muscle disease
- Terminal liver failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olav Rooyackers, Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 14186
Jonathan Grip, MD, PhD, +46 73 623 09 06, jonathan.grip@regionstockholm.se
Christian Ahlstedt, MD, +4670 729 3514
About this study
Official title: Lactate Kinetics in Patients Treated for Septic Shock
Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.
Read the 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.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Isotopically labeled lactate
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotopically labeled lactateOther
A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients receive the same intervention/sampling protocol Receives: Other: Isotopically labeled lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body rate of appearance of lactate
The total amount of lactate produced per unit of time
Measured: 2 hours
Secondary outcomes (1)
Clearance of lactate
Amount of plasma that is cleared from lactate per unit of time
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Dec 2022
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, European Society of Intensive Care Medicine, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
- Responsible party
- Principal investigator, Jonathan Grip, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349370
- Sponsor's protocol ID
- K 2022-4066
- Acronym
- LKISS
- Status last verified
- May 2025
- First submitted
- 22 Apr 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32041652
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Kinetics in Patients Treated for Septic Shock
- ClinicalTrials.gov ID
- NCT05349370
- Acronym / sponsor ID
- LKISS / K 2022-4066
- Conditions
- Sepsis, Septic Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Region Stockholm, European Society of Intensive Care Medicine, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Other: Isotopically labeled lactateAll patients receive the same intervention/sampling protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sepsis
- Age >17 years
- Arterial catheter
- Lactate > 2 mmol at any time point prior to inclusion
Key exclusion criteria (3 listed)
- Mitochondrial defect
- Degenerative muscle disease
- Terminal liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotopically labeled lactateA bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn | Other | All patients |
Primary outcome
Whole body rate of appearance of lactate
Time frame: 2 hours
The total amount of lactate produced per unit of time
1 secondary outcome
Clearance of lactate
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Results publication: PubMed 32041652Grip 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olav Rooyackers, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotopically labeled lactate in people with Sepsis and Septic Shock, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Grip, MD, PhD (+46736230906, jonathan.grip@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body rate of appearance of lactate (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.