NCT05349370

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
8mo left

Started Dec 2022

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

April 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

3.3 years

First QC Date

April 22, 2022

Last Update Submit

May 20, 2025

Conditions

SepsisSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • Whole body rate of appearance of lactate

    The total amount of lactate produced per unit of time

    2 hours

Secondary Outcomes (1)

  • Clearance of lactate

    2 hours

Study Arms (1)

All patients

EXPERIMENTAL

All patients receive the same intervention/sampling protocol

Other: Isotopically labeled lactate

Interventions

Isotopically labeled lactateOTHER

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

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sepsis
  • Age \>17 years
  • Arterial catheter

You may not qualify if:

  • Mitochondrial defect
  • Degenerative muscle disease
  • Terminal liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 14186, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32041652BACKGROUND

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Jonathan Grip, MD, PhD

CONTACT

+46736230906jonathan.grip@regionstockholm.se

Olav Rooyackers, Professor

CONTACT

olav.rooyackers@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 27, 2022

Study Start

December 28, 2022

Primary Completion

March 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)