ANZCTR - Registration

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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]

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

Organ failure in shock without sepsis

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Cardiovascular

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]

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]

Mitochondrial respiratory function by using the technique of high resolution respirometry using machines called oxygraphs

Timepoint [1]

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]

Mitochondrial reactive oxygen species production by measuring superoxide production using flow cytometry equipment.

Timepoint [1]

Secondary outcome [2]

Fatigue questionnaire score

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Address Level 3 - ProCARE Building, 110 Stanley Street (access via Grafton Mews), Auckland 1010

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Auckland City Hospital

Address

2 Park Road,
Grafton,
Auckland 1023

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

The University of Auckland

Address [1]

Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023

Country [1]

New Zealand

Other collaborator category [1]

University

Name [1]

The University of Auckland

Address [1]

School of Biological Sciences
3a Symonds Street
Auckland 1010

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Ethics Committee

Ethics committee address [1]

Private Bag 92-522, Wellesley St
Auckland 1141

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

14/01/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Mandira Chakraborty

Address

Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Grafton Road
Auckland 1010

Country

New Zealand

Phone

+6421438965

Fax

[email protected]

Contact person for scientific queries

Name

Mandira Chakraborty

Address

Department of Surgery
Level 12, Support Block
Auckland City Hospital
2 Grafton Road
Auckland 1010

Country

New Zealand

Phone

+6421438965

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Mitochondrial dysfunction in peripheral blood mononuclear cells in early experimental and clinical acute pancreatitis.	2016	https://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.

Trial Review

Documents added manually

Documents added automatically