Lactate Kinetics in Septic Shock

NCT ID: NCT05349370

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2026-12-31

Brief Summary

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Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

Detailed Description

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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 รก 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

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Sepsis Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All patients

All patients receive the same intervention/sampling protocol

Group Type EXPERIMENTAL

Isotopically labeled lactate

Intervention Type OTHER

A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn

Interventions

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Isotopically labeled lactate

A bolus dose of isotopically labeled lactate is given and blood samples from existing catheters are drawn

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Grip

Principal Investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jonathan Grip, MD, PhD

Role: CONTACT

+46736230906

Olav Rooyackers, Professor

Role: CONTACT

Facility Contacts

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Jonathan Grip, MD, PhD

Role: primary

+46 73 623 09 06

Christian Ahlstedt, MD

Role: backup

+4670 729 3514

References

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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.

Reference Type BACKGROUND
PMID: 32041652 (View on PubMed)

Other Identifiers

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K 2022-4066

Identifier Type: -

Identifier Source: org_study_id

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