Evaluation of mortality and morbidity outcome in patients with septic shock due to intra-abdominal sepsis using Alteco Lipopolysaccharide adsorption technique

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000892011

Enrollment

Registered

2010-10-20

Start date

2010-03-01

Completion date

2013-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pati

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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)

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

Outcome results