Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000310369
Ethics application status
Approved
Date submitted
3/02/2017
Date registered
27/02/2017
Date last updated
27/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a method for describing lactate kinetics in ICU patients – a pilot study in healthy volunteers.
Scientific title
Development of a method for describing lactate kinetics in ICU patients using a stable labeled 13C-lactate bolus – a pilot study in healthy volunteers.
Secondary ID [1] 291072 0
None
Universal Trial Number (UTN)
U1111-1192-4875
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care patients 301883 0
Condition category
Condition code
Metabolic and Endocrine 301548 301548 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy volunteers will receive a peripheral venous catheter and an arterial catheter. They will then receive a bolus of 13-labelled lactate (2.7mg/kg) and blood samples will be drawn continuously during the next two hours (not more than 100ml blood will be drawn).
Intervention code [1] 297061 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300949 0
Enrichment of 13-lactate. Rate of appearance and rate of disappearance of endogenous lactate will be assessed by Gas Chromatography-Mass spectrometry (GC-MS)
Timepoint [1] 300949 0
Samples are taken at baseline and throughout the following two hours, every other minute the first hour and every fifth minute the second hour (t=0 and at time points: 2, 4, 6,... 56, 58, 60, 65, 70, 75... 110, 115, 120)
Secondary outcome [1] 331258 0
Normalization of lactate levels after bolus, defined as return to baseline levels (t=0).
Timepoint [1] 331258 0
Samples are taken at baseline and throughout the following two hours, every other minute the first hour and every fifth minute the second hour (t=0 and at time points: 2, 4, 6,... 56, 58, 60, 65, 70, 75... 110, 115, 120)

Eligibility
Key inclusion criteria
Healthy volunteers without ongoing mediaction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Abnormalities on lab screening, including pregnancy test

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
Mathematical modeling of rate of appearance / disappearance.
ANOVA for repeated measurements and student´s t-test to compare individual time points will be used for statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2017
Date of last participant enrolment
Anticipated
31/03/2017
Actual
Date of last data collection
Anticipated
31/03/2017
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 8620 0
Sweden
State/province [1] 8620 0

Funding & Sponsors
Funding source category [1] 295512 0
Hospital
Name [1] 295512 0
Karolinska University Hospital
Country [1] 295512 0
Sweden
Funding source category [2] 295515 0
University
Name [2] 295515 0
Karolinska Institutet
Country [2] 295515 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] 294530 0
None
Name [1] 294530 0
None
Address [1] 294530 0
Country [1] 294530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296839 0
Regional Ethics Committee Stockholm
Ethics committee address [1] 296839 0
Tomtebodavägen 18A,
FE 289
171 77 STOCKHOLM
Ethics committee country [1] 296839 0
Sweden
Date submitted for ethics approval [1] 296839 0
31/03/2016
Approval date [1] 296839 0
04/05/2016
Ethics approval number [1] 296839 0
2016/722-31/1

Summary
Brief summary
In order to study lactate kinetics in ICU patients with a minimally invasive technique we are performing this pilot study on healthy volunteers.
After a standard health form, medical examination and testing the fasting subjects will receive venous and arterial catheters. Base line samples are drawn and frozen. A bolus of stable isotopically labeled 13C-lactate will be given (2.7mg/kg body weight). Blood samples will be drawn at 37 time points throughout 2 hours (not more than 100ml blood al together). Samples will be analyzed at bedside analyzer and snap frozen for later analysis for relationship between 13C-labelled and normal lactate.
Subjects will monitored with ECG, pulsoximetry and blood pressure throughout the experiment.
Trial website
No
Trial related presentations / publications
No
Public notes
No

Contacts
Principal investigator
Name 72190 0
Prof Jan Wernerman
Address 72190 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 72190 0
Sweden
Phone 72190 0
+46858586337
Fax 72190 0
Email 72190 0
[email protected]
Contact person for public queries
Name 72191 0
Jonathan Grip
Address 72191 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 72191 0
Sweden
Phone 72191 0
+46736230906
Fax 72191 0
Email 72191 0
[email protected]
Contact person for scientific queries
Name 72192 0
Jonathan Grip
Address 72192 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K32
141 86 Stockholm Sweden
Country 72192 0
Sweden
Phone 72192 0
+46736230906
Fax 72192 0
Email 72192 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23483Ethical approval   

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.