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Trial registered on ANZCTR


Registration number
ACTRN12610000892011
Ethics application status
Approved
Date submitted
18/10/2010
Date registered
20/10/2010
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of mortality and morbidity outcome in patients with septic shock due to intra-abdominal sepsis using Alteco Lipopolysaccharide adsorption technique
Scientific title
To evaluate the mortality and morbidity outcome of endotoxin adsorption using Alteco Lipopolysaccharide adsorption technique in patient with septic shock due to intra-abdominal sepsis, compare with those using conventional therapy
Secondary ID [1] 252903 0
HKClinicalTrials.com (HKCTR-1129)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with septic shock due to intra-abdominal sepsis required vasopressor support 258438 0
Condition category
Condition code
Infection 258603 258603 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group (Lipopolysaccharide adsorption group) will receive Alteco Lipopolysaccharide adsorber in addition to standard medical therapy. Patient will have hemodialysis catheter insertion over femoral vein or internal jugular vein for blood access. Hemoperfusion (a technique involves passing large volumes of blood over an adsorbent substance) using Alteco Lipopolysaccharide adsorber at blood flow rate of 120-150ml/h will be conducted as soon as possible after randomization. Each patient will have two 2-hourly sessions of Lipopolysaccharide adsorption 24hrs apart. In between, renal replacement therapy will be provided if clinically indicated based on usual practice
Intervention code [1] 257434 0
Treatment: Devices
Comparator / control treatment
Control group will have standard medical therapy for septic shock namely: control of septic sources, antibiotic, fluid challenge, vasopressor and stress dose steroid. Renal replacement therapy will be provided as indicated.
Control group
Active

Outcomes
Primary outcome [1] 259451 0
Sequential Organ Failure Assessment (SOFA) score changes
Tool used for assessment: SOFA score
Timepoint [1] 259451 0
0, 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 56, 64 and 72 hrs following randomization
Primary outcome [2] 259467 0
Mean arterial pressure (MAP)
Tool used for assessment: Invasive continuous arterial blood pressure monitoring
Timepoint [2] 259467 0
0, 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 56, 64 and 72 hrs following randomization
Primary outcome [3] 259468 0
Vasopressor (Noradrenaline/ adrenaline) dosage
Tool used for assessment: Patient's electronic medication record on use of vasopressor
Timepoint [3] 259468 0
0, 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 56, 64 and 72 hrs following randomization
Secondary outcome [1] 266009 0
Intensive care unit (ICU) length of stay
Tool used for assessment: Data based on electronic medical record
Timepoint [1] 266009 0
ICU discharge
Secondary outcome [2] 266039 0
Hospital length of stay
Tool used for assessment: Data based on electronic medical record
Timepoint [2] 266039 0
Hospital discharge
Secondary outcome [3] 266040 0
Hospital mortality
Tool used for assessment: Data based on electronic medical record on patient's outcome
Timepoint [3] 266040 0
Hospital death
Secondary outcome [4] 266041 0
28 days mortality
Tool used for assessment: Data based on electronic medical record, follow up record or direct telephone contact
Timepoint [4] 266041 0
Mortality at 28th day of randomization
Secondary outcome [5] 266042 0
Requirement of renal replacement therapy (RRT)
Tool used for assessment: Indication of RRT based on clinical and laboratory assessment (eg. electrolyte/ metabolic disturbance, fluid overload etc).
Timepoint [5] 266042 0
Any time from 0-72 hrs of randomization
Secondary outcome [6] 266043 0
Inflammatory markers (TNF-alpha, CRP) changes (For intervention group only)
Tool used for assessment: blood test of TNF-alpha and CRP
Timepoint [6] 266043 0
Before starting of 1st LPS absorption
Immediately post 1st LPS absorption
6hrs post 1st LPS absorption
Before starting of 2nd LPS absorption
Immediately post 2nd LPS absorption
24hrs post 2nd LPS absorption

Eligibility
Key inclusion criteria
1. Septic shock (definition based on ACCP/ SCCM criteria) due to intra-abdominal sepsis and,
2. Require vasopressor support (single strength noradrenaline >=10ml/h), and
3. On steroid (hydrocortisone 200-300mg/d or equivalent)
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication for heparin/ low molecular heparin use (hypersensitivity to heparin/ LMWH or any component of the formulation; known history of heparin induced thrombocytopenia; severe thrombocytopenia (<50,000 / mm3); uncontrolled active bleeding except when due to disseminated intravascular coagulation)
2. Pregnancy
3. Terminal illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients admitted to our intensive care unit with septic shock due to intra-abdominal sepsis who required vasopressor support will be approached. Consent will be obtained from patient or their close relatives.
Envelop with randomized result will be opened and the treatment will be given as such
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
This study was terminated early as interim analysis showed a low probability
of signifi cant fi ndings.
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] 2980 0
Hong Kong
State/province [1] 2980 0

Funding & Sponsors
Funding source category [1] 257872 0
Self funded/Unfunded
Name [1] 257872 0
Address [1] 257872 0
Country [1] 257872 0
Primary sponsor type
Hospital
Name
Department of intensive care, Pamela Youde Nethersole Eastern Hospital
Address
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong, China
Country
Hong Kong
Secondary sponsor category [1] 257072 0
Commercial sector/Industry
Name [1] 257072 0
Associated Medical Supplies Co. Ltd.
Address [1] 257072 0
Room 1201, Fo Tan Industrial Centre
26 Au Pui Wan Street, Fo Tan
New Territories, Hong Kong
Country [1] 257072 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259901 0
Hong Kong East Cluster ethics committee
Ethics committee address [1] 259901 0
Hong Kong East Cluster ethics committee
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong, China
Ethics committee country [1] 259901 0
Hong Kong
Date submitted for ethics approval [1] 259901 0
27/11/2009
Approval date [1] 259901 0
22/01/2010
Ethics approval number [1] 259901 0
HKEC-2009-096

Summary
Brief summary
Severe sepsis / septic shock are common in ICU setting which carry very high mortality (30-50%) despite optimal treatment. Endotoxin (lipopolysaccharide, LPS), one of the principle components on the outer membranes of gram-negative bacteria, is considered relevant to their pathogenesis. Sorbent can effectively bind endotoxin and potentially interrupt the biological cascade of sepsis. Based on published data, LPS adsorption could improve blood pressure, oxygenation and mortality (absolute risk reduction 21%).
This study aimed to investigate the mortality/ morbidity benefit of Alteco LPS adsorber, one of the LPS adsorption devices currently available in market, in patient with septic shock due to intra-abdominal sepsis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31798 0
Dr Dr Shum Hoi Ping
Address 31798 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong SAR
Country 31798 0
Hong Kong
Phone 31798 0
+852-25956111
Fax 31798 0
Email 31798 0
shumhp@ha.org.hk
Contact person for public queries
Name 15045 0
Dr Dr. Hoi-Ping Shum
Address 15045 0
Department of Intensive Care Unit
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong, China
Country 15045 0
Hong Kong
Phone 15045 0
852-25956111
Fax 15045 0
Email 15045 0
shumhp@ha.org.hk
Contact person for scientific queries
Name 5973 0
Dr Dr. Hoi-Ping Shum
Address 5973 0
Department of Intensive Care Unit
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong, China
Country 5973 0
Hong Kong
Phone 5973 0
852-25956111
Fax 5973 0
Email 5973 0
shumhp@ha.org.hk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary