Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000792426
Ethics application status
Approved
Date submitted
7/04/2016
Date registered
17/06/2016
Date last updated
17/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Lactate metabolism in Intensive Care Unit (ICU) patients with severe sepsis / septic shock with normal and elevated lactate values.
Scientific title
Description of muscle lactate metabolism in ICU patients with severe sepsis/septic shock in a two-compartment model using stable isotopes. An experimental, descriptive, open clinical trial.
Secondary ID [1] 289219 0
None
Universal Trial Number (UTN)
U1111-1180-4871
Trial acronym
2PLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis 297930 0
Septic shock 298778 0
Condition category
Condition code
Infection 298095 298095 0 0
Other infectious diseases
Inflammatory and Immune System 298096 298096 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be given primed infusions of both D5-labelled Phenylalanine (bolus of 0.5 mg/kg and infusion of 0.5 mg/kg/h) and 13C-labelled Lactate (bolus of 1 mg/kg and infusion of 3.65 mg/kg/h) during 3 hours, when these will have reached steady state. Patients will receive a femoral venous catheter, blood samples will be collected and blood flow in the leg examined using doppler-ultrasound. Clinical data will be collected from electronic charts.
Intervention code [1] 294134 0
Diagnosis / Prognosis
Comparator / control treatment
The study aims to describe and compare lactate metabolism in patients with severe sepsis / septic shock with normal lactate (<2mmol/L) and elevated lactate (>3mmol/L)
Control group
Active

Outcomes
Primary outcome [1] 297611 0
Difference in whole body lactate kinetics between the groups.

By analyzing blood samples for relationship between labelled and unlabelled lactate with Gas Chromatography-Mass Spectrometry (GC-MS), lactate kinetics (rate of appearance and rate of disappearance) can be derived through mathematical models.
Timepoint [1] 297611 0
Serial blood samples (n=4) will be drawn every five minutes between t=195 and t=210 after start of the infusions. Lactate kinetics will be calculated for each of these data points as well as means of the four.
Primary outcome [2] 298301 0
Difference in skeletal muscle lactate kinetics between the groups.

By analyzing blood samples for relationship between labelled and unlabelled lactate with Gas Chromatography-Mass Spectrometry (GC-MS), lactate kinetics (rate of appearance and rate of disappearance) can be derived through mathematical models. By taking simultaneous samples from artery and vein and combining them with femoral blood flow, quantification of production and uptake in the leg can be performed
Timepoint [2] 298301 0
Serial blood samples (n=4) will be drawn every five minutes between t=195 and t=210 after start of the infusions, from artery and femoral vein. Lactate kinetics will be calculated for each of these data points as well as means of the four.
Blood flow will be measured before and after the sampling and mean will be used for quantification of lactate kinetics.
Secondary outcome [1] 321579 0
Difference in whole body Phenylalanine kinetics between the groups.

By analyzing blood samples for relationship between labelled and unlabelled phenylalanine with Gas Chromatography-Mass Spectrometry (GC-MS), kinetics (rate of appearance and rate of disappearance) can be derived through mathematical models.
Timepoint [1] 321579 0
Serial blood samples (n=4) will be drawn every five minutes between t=195 and t=210 after start of the infusions. Lactate kinetics will be calculated for each of these data points as well as means of the four.
Secondary outcome [2] 322345 0
Mortality
Timepoint [2] 322345 0
28 days after study

Eligibility
Key inclusion criteria
Severe sepsis / septic shock within 72 hours of onset. Lactate <2mmol/L or >3mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Muscle disorders, Metformin treatment within the last five days, ongoing dialysis at time of investigation, lack of informed consent.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Assuming a variation twice that of healthy volunteers in our previous study, the study is powered to have 80% chance to detect a 30% difference in whole body, and 50% difference in muscle, rate of appearance between the groups with high and normal lactate, with a alpha-level of a=0.05. These numbers can be compared to the change in rate of appearance caused by adrenaline of 300% (which increased plasma levels from 1.1 to 4.0 mmol/L). Student´s t-test will be used for comparisons between the groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2016
Actual
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 7656 0
Sweden
State/province [1] 7656 0
Stockholm

Funding & Sponsors
Funding source category [1] 293067 0
Government body
Name [1] 293067 0
Stockholm County
Country [1] 293067 0
Sweden
Primary sponsor type
University
Name
Karolinska Institutet
Address
Clintec, dept of Anesthesiology and Intensive Care
141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 292112 0
None
Name [1] 292112 0
Address [1] 292112 0
Country [1] 292112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294575 0
Regional Ethical Review Board in Stockholm
Ethics committee address [1] 294575 0
Ethics committee country [1] 294575 0
Sweden
Date submitted for ethics approval [1] 294575 0
15/01/2016
Approval date [1] 294575 0
17/02/2016
Ethics approval number [1] 294575 0
2016/106-31/4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64210 0
Prof Olav Rooyackers
Address 64210 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K31 141 86 Stockholm
Country 64210 0
Sweden
Phone 64210 0
+46739661645
Fax 64210 0
Email 64210 0
[email protected]
Contact person for public queries
Name 64211 0
Jonathan Grip
Address 64211 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K31 141 86 Stockholm
Country 64211 0
Sweden
Phone 64211 0
+46736230906
Fax 64211 0
Email 64211 0
[email protected]
Contact person for scientific queries
Name 64212 0
Jonathan Grip
Address 64212 0
Karolinska University Hospital
Dept. of Anesthesiology and Intensive Care
K31 141 86 Stockholm
Country 64212 0
Sweden
Phone 64212 0
+46736230906
Fax 64212 0
Email 64212 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.