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Polymyxin B-immobilised haemoperfusion and mortality in critically ill patients with sepsis/septic shock: a protocol
Tomoko Fujii1,2, Riki Ganeko3, Yuki Kataoka4
1Department of Epidemiology and Preventive Service, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Introduction:
Polymyxin-B immobilised haemoperfusion (PMX-HP) is a promising adjuvant strategy for the treatment of sepsis and septic shock. PMX-HP therapy works by clearing circulating endotoxin through binding to polymyxin-immobilised fibres during haemoperfusion. Small clinical trials have shown that PMX-HP therapy is associated with improved haemodynamic profile, oxygenation and survival. However, clear inferences have been largely inconclusive due to limitations in study design (eg, small, unblinded) and generalisability. We therefore propose to perform an up-to-date systematic review and evidence synthesis to describe the efficacy, safety and effectiveness of PMX-HP for adult patients with sepsis or septic shock.
Methods And Analysis:
We will search the following databases from 1946 to 2016 MEDLINE (Ovid), EMBASE (Ovid), Cochrane Library, Health Technology Assessment Database (HTA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed and 'Igaku Chuo Zasshi' (ICHUSHI) for randomised controlled trials of PMX-HP in critically ill patients with sepsis or septic shock. There will be no language restrictions in the electronic search for studies. Two reviewers will extract data and appraise the quality of each study independently. The primary outcome will be the pooled risk ratio of 28-day all-cause mortality. Serious adverse events and changes in organ dysfunction scores will also be evaluated. The secondary outcomes will be 90-day all-cause mortality, changes in haemodynamic profile and endotoxin levels, and health services use.
Ethics And Dissemination:
Our systematic review will synthesise the evidence on use of the PMX-HP as an adjuvant therapy in sepsis/septic shock to improve patient-centred, physiological and health services outcomes. Research ethics is not required for this review. The study will be disseminated by peer-reviewed publication and conference presentation.
Trial Registration Number:
CRD42016038356.
Insights
Polymyxin-B immobilised haemoperfusion (PMX-HP) is a potential sepsis treatment. This systematic review synthesizes evidence on PMX-HP
Area of Science:
- Critical care medicine
- Nephrology
- Infectious diseases
Background:
- Polymyxin-B immobilised haemoperfusion (PMX-HP) is an adjuvant therapy for sepsis and septic shock.
- PMX-HP removes endotoxins from circulation, potentially improving patient outcomes.
- Previous clinical trials suggest benefits in hemodynamics, oxygenation, and survival, but require further validation.
Purpose of the Study:
- To conduct a systematic review and evidence synthesis on the efficacy, safety, and effectiveness of PMX-HP in adult sepsis/septic shock patients.
- To consolidate current evidence to address limitations in previous study designs and generalizability.
- To provide an up-to-date assessment of PMX-HP as an adjuvant therapy.
Main Methods:
- Systematic search of multiple databases (MEDLINE, EMBASE, Cochrane, etc.) from 1946 to 2016 for randomized controlled trials.
- No language restrictions for study inclusion.
- Data extraction and quality appraisal by two independent reviewers; primary outcome: 28-day all-cause mortality; secondary outcomes: 90-day mortality, adverse events, organ dysfunction, hemodynamics, endotoxin levels.
Main Results:
- The review will synthesize findings from eligible randomized controlled trials.
- Pooled risk ratio of 28-day all-cause mortality will be calculated.
- Evaluation of serious adverse events and changes in organ dysfunction scores.
Conclusions:
- The systematic review will provide a comprehensive synthesis of evidence regarding PMX-HP for sepsis and septic shock.
- Findings will inform clinical practice and future research on this adjuvant therapy.
- Dissemination through peer-reviewed publication and conference presentation.
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