Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000047897
Ethics application status
Approved
Date submitted
11/11/2011
Date registered
10/01/2012
Date last updated
11/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mitochondrial function and markers of oxidative stress in patients with organ failure
Scientific title
Peripheral blood taking to measure mitochondrial function and markers of oxidative stress in patients with organ failure.
Secondary ID [1] 252860 0
None
Universal Trial Number (UTN)
Trial acronym
MOSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Organ failure in septic shock 258383 0
Organ failure in shock without sepsis 258384 0
Condition category
Condition code
Inflammatory and Immune System 258556 258556 0 0
Other inflammatory or immune system disorders
Cardiovascular 279336 279336 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A. Peripheral blood taking daily for the first 7 days, once at 3 weeks and once at 6 months from the time of organ failure (OF) in septic shock or shock without sepsis. Participants will be recruited over a 18 month period

B. Filling out a fatigue questionnaire (Identity-Consequence Fatigue Scale) at each time point when blood is taken as practical
Intervention code [1] 257378 0
Not applicable
Comparator / control treatment
The study is an observational study and doesn't have any treatments associated with it.
The study has 3 groups: 1) patients with organ failure with septic shock (n=15) 2) patients with organ failure with non-septic shock (n=15) 3) healthy volunteers age and gender matched from the community (n=15) Mitochondrial function from peripheral blood is measured from all 3 groups and compared.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279938 0
Mitochondrial respiratory function by using the technique of high resolution respirometry using machines called oxygraphs
Timepoint [1] 279938 0
For patients with septic shock/shock without sepsis: Daily for the first 7 days, once in 3rd week, once at 6 months
For healthy volunteers: Peripheral blood taken twice within 1 month from the first blood take
Secondary outcome [1] 294811 0
Mitochondrial reactive oxygen species production by measuring superoxide production using flow cytometry equipment.
Timepoint [1] 294811 0
For patients with septic shock/shock without sepsis: Daily for the first 7 days, once in 3rd week, once at 6 months
For healthy volunteers: Peripheral blood taken twice within 1 month from the first blood take
Secondary outcome [2] 294812 0
Fatigue questionnaire score
Timepoint [2] 294812 0
For patients only: at 6 months

Eligibility
Key inclusion criteria
For patients: Over 15 with either septic shock or shock from any other cause. All patients must have organ failure of one or more organ systems.

For heathy volunteers: Over 15 without any known medical conditions and not on any medications. Age and gender matched to patients. Eligible healthy volunteers will be deemed healthy with a help of a questionnaire detailing their medical history.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for patients: Known mitochondrial diseases, hematological malignancies are the exclusion criteria for participating patients.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 2968 0
New Zealand
State/province [1] 2968 0

Funding & Sponsors
Funding source category [1] 284188 0
Government body
Name [1] 284188 0
Health Research Council of New Zealand
Country [1] 284188 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
2 Park Road,
Grafton,
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 269144 0
University
Name [1] 269144 0
The University of Auckland
Address [1] 269144 0
Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country [1] 269144 0
New Zealand
Other collaborator category [1] 260339 0
University
Name [1] 260339 0
The University of Auckland
Address [1] 260339 0
School of Biological Sciences
3a Symonds Street
Auckland 1010
Country [1] 260339 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286154 0
Northern X Ethics Committee
Ethics committee address [1] 286154 0
Private Bag 92-522, Wellesley St
Auckland 1141
Ethics committee country [1] 286154 0
New Zealand
Date submitted for ethics approval [1] 286154 0
Approval date [1] 286154 0
14/01/2011
Ethics approval number [1] 286154 0
NTX10/11/119

Summary
Brief summary
Multiple organ dysfunction syndrome (MODS) is the primary cause of mortality and morbidity in intensive care units. MODS is associated with common intensive care unit diseases such as severe sepsis, septic shock, hemorrhagic shock and severe acute pancreatitis. In MODS, despite adequate delivery of oxygen, cells are not able to use this oxygen. This phenomenon is called cytopathic hypoxia and is thought to be due to mitochondrial dysfunction (MD). In health, mitochondria utilise most of the oxygen delivered to cells to generate the energy currency of cells called adenine triphosphate. However, it is not known what happens to mitochondrial function as MODS progresses and whether mitochondrial function (MF) can predict severity of organ failure. It is also not known whether the pattern of MD is similar in diseases such as shock with sepsis, and shock without sepsis compared to healthy volunteers. This study will measure MF from peripheral blood at multiple time points from patients with shock with sepsis, shock without sepsis and healthy volunteers in order to answer these questions.
Often, after many months after discharge from intensive care unit, patients continue to still feel fatigued, it is not known whether this fatigue has any correlation with MF. This study will also address this question.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31764 0
Address 31764 0
Country 31764 0
Phone 31764 0
Fax 31764 0
Email 31764 0
Contact person for public queries
Name 15011 0
Mandira Chakraborty
Address 15011 0
Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Grafton Road
Auckland 1010
Country 15011 0
New Zealand
Phone 15011 0
+6421438965
Fax 15011 0
Email 15011 0
[email protected]
Contact person for scientific queries
Name 5939 0
Mandira Chakraborty
Address 5939 0
Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Grafton Road
Auckland 1010
Country 5939 0
New Zealand
Phone 5939 0
+6421438965
Fax 5939 0
Email 5939 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
SourceTitleYear of PublicationDOI
EmbaseMitochondrial dysfunction in peripheral blood mononuclear cells in early experimental and clinical acute pancreatitis.2016https://dx.doi.org/10.1016/j.pan.2016.06.659
N.B. These documents automatically identified may not have been verified by the study sponsor.