The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000626369
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
1/05/2017
Date last updated
15/02/2019
Date data sharing statement initially provided
15/02/2019
Date results information initially provided
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Production and utilization of lactate in an intensive care patient population
Scientific title
Description of lactate kinetics in ICU patients using a bolus injection of 13C-labeled lactate - an experimental open-label non-randomized clinical trial
Secondary ID [1] 291377 0
Nill
Universal Trial Number (UTN)
U1111-1193-9254
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mixed Intensive Care Unit patients with single or multiple organ failure 302380 0
Condition category
Condition code
Metabolic and Endocrine 301963 301963 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each ICU patient will receive a single bolus dose of 13C-labeled lactate (2.7mg/kg body weight). Existing arterial and venous lines will be used. Blood samples will be drawn at t=0 and then every two minutes during the first hour and every fifth minute for the second hour (t=2,4,6...56,58,60,65,70...110,115,120)
Intervention code [1] 297414 0
Other interventions
Comparator / control treatment
No control group will be recruited but results will be compered to previous trials on healthy volunteers.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301394 0
Rate of appearance of lactate in blood.
Timepoint [1] 301394 0
Samples are taken at baseline and then throughout the first two hours after injection of 13C-lactate bolus is given. Initially every two minutes during the first hour and then every fifth minute during the second hour (t=0,2, 4, 6 .... 56, 58, 60, 65, 70...110, 115, 120)
Primary outcome [2] 301605 0
Rate of disappearance of lactate in blood
Timepoint [2] 301605 0
Samples are taken at baseline and then throughout the first two hours after injection of 13C-lactate bolus is given. Initially every two minutes during the first hour and then every fifth minute during the second hour (t=0,2, 4, 6 .... 56, 58, 60, 65, 70...110, 115, 120)
Secondary outcome [1] 332535 0
Correlation between absolute levels of lactate in blood and rate of appearance of lactate in blood will be evaluated as a secondary outcome
Timepoint [1] 332535 0
Samples are taken at baseline and then throughout the first two hours after injection of 13C-lactate bolus is given. Initially every two minutes during the first hour and then every fifth minute during the second hour (t=0,2, 4, 6 .... 56, 58, 60, 65, 70...110, 115, 120)

Eligibility
Key inclusion criteria
- Patients treated in the ICU who have an existing, functioning arterial and venous lines
- Informed consent to participate (can be given by next of kin when appropriate)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwillingness to participate, Unable to obtain informer consent. Terminal liver insufficiency.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
After linear approximation of the decay in 13C-lactate enrichment for each subject, individual kinetics will be derived and means compared in group and to previous series in healthy volunteers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8719 0
Sweden
State/province [1] 8719 0
Stockholm

Funding & Sponsors
Funding source category [1] 295850 0
Hospital
Name [1] 295850 0
Karolinska University Hospital
Address [1] 295850 0
Karolinska University Hospital
Dept of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country [1] 295850 0
Sweden
Funding source category [2] 295860 0
University
Name [2] 295860 0
Karolinska Institutet
Address [2] 295860 0
CLINTEC, dept of Anesthesiology and Intensive Care
K32
141 86 Stockholm Swedenv
Country [2] 295860 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Karolinska University Hospital
Dept of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country
Sweden
Secondary sponsor category [1] 294711 0
None
Name [1] 294711 0
None
Address [1] 294711 0
Country [1] 294711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297131 0
Regional Ethics Committee Stockholm
Ethics committee address [1] 297131 0
Tomtebodavägen 18A,
FE 289
171 77 STOCKHOLM
Ethics committee country [1] 297131 0
Sweden
Date submitted for ethics approval [1] 297131 0
31/03/2016
Approval date [1] 297131 0
04/05/2016
Ethics approval number [1] 297131 0
2016/722-31/1

Summary
Brief summary
In order to describe lactate metabolism in critically ill patients our group has designed a simple, minimally invasive protocol in healthy volunteers. In our current study we aim to use this protocol in a mixed ICU population.
Briefly patients will be recruited after informed consent (from next of kin when appropriate). After this baseline samples will be drawn and a bolus dose of 13C-labeled lactate (2.7mg/kg) will be given. Blood samples will be drawn over two hours (no more than 100 ml all together), samples will be frozen and analyzed for lactate concentration and 13C-enrichment. An interim analysis will be conducted after the first 6 patients. Data will be collected from electronical charting systems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73086 0
Prof Jan Wernerman
Address 73086 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 73086 0
Sweden
Phone 73086 0
+46858586337
Fax 73086 0
Email 73086 0
jan.wernerman@sll.se
Contact person for public queries
Name 73087 0
Dr Jonathan Grip
Address 73087 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 73087 0
Sweden
Phone 73087 0
+46736230906
Fax 73087 0
Email 73087 0
jonathan.grip@ki.se
Contact person for scientific queries
Name 73088 0
Dr Jonathan Grip
Address 73088 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 73088 0
Sweden
Phone 73088 0
+46736230906
Fax 73088 0
Email 73088 0
jonathan.grip@ki.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small experimental trial. Individual enrichment values will be submitted as supplementary data file when trial is published.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
The protocol yielded results similar to those published using other protocols in healthy volunteers. ICU patients with normal lactate concentration showed similar kinetics to healthy controls. Sampling could be reduced from 43 to 14 sampled with maintained accuracy.