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Impact of Early Peri-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery

Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Sepsis; Peritonitis; Colon Perforation

Intervention: Polymyxin-B hemoperfusion (Other); Control (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Jerome Pugin, Professor, Study Director, Affiliation: Hôpitaux Universitaires de Genève

Overall contact:
Gordana Pavlovic, MD, Phone: +41 795532098, Email: gordana.pavlovic@hcuge.ch

Summary

Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed pathogens and associated with high levels of endotoxin. The injury to the endothelium results in an increase of endothelial permeability, interstitial edema and release of nitric oxide (NO) that is a very potent vasodilatator. [6] Polymyxins obtained from the Gram-positive bacterium Bacillus polymyxa are antibiotics known for their ability to bind LPS in the outer membrane of the Gram-negative bacterial cell wall as well as free endotoxins with high affinity. Polymyxin-B has been shown to block the activation of cells by a wide variety of LPS. Studies converged to show an improvement in the treatment of septic shock by removing circulating endotoxin. Starting Polymyxin-B hemoperfusion during the operative time is to block the initiation of various deleterious biological cascades induced by endotoxemia such as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ dysfunction and death.

Clinical Details

Official title: Impact of Early Per-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The primary endpoint will be requirement of vasopressors during the first 72 hrs after the beginning of the PMX hemoperfusion using the "inotropic score"

Secondary outcome:

The secondary endpoint will be the variation of MAP, during the first 72 hrs after the beginning of the PMX hemoperfusion

The secondary endpoint will be the variation of "vasopressor dependency index", during the first 72 hrs after the beginning of the PMX hemoperfusion

The secondary endpoint will be the variation of Pa02/Fi02, during the first 72 hrs after the beginning of the PMX hemoperfusion

The secondary endpoint will be the variations of the total SOFA score during the first 7 days after the beginning of the PMX hemoperfusion

The secondary endpoint will be the 28-days mortality

The secondary endpoint will be the 90-days mortality

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults > 18 years

- Severe sepsis*or septic shock as define by the ACCCP/SCCM consensus conference, of

abdominal origin

- Need for emergent abdominal surgery procedure under general anesthesia with expected

duration of ≥ 120 min (in and out patients) for bowel perforation, ileus or peritonitis Exclusion Criteria:

- Patients younger than 18 years

- Organ transplantation in the last year

- Terminally ill patients: do-not-resuscitate order, perceived to die within 48 hrs of

admission

- Known pregnancy or diagnosed by US or Ct-scan (>14 weeks)

- History of sensitivity to polymyxin-B or to anticoagulant ( heparin)

- Uncontrolled hemorrhage within the last 24h

- Severe granulocytopenia ( leukocyte count of < 500/µL)

- Severe thrombocytopenia ( platelets count of < 30'000/µL)

- Need for CPR pre-operatively

Locations and Contacts

Gordana Pavlovic, MD, Phone: +41 795532098, Email: gordana.pavlovic@hcuge.ch

Emergency operating room, Geneva Cantonal Hospital, Geneva 1211, Switzerland; Recruiting
Gordana Pavlovic, MD, Phone: +41 795532098, Email: gordana.pavlovic@hcuge.ch
Gordana Pavlovic, MD, Principal Investigator
Additional Information

Starting date: January 2012
Last updated: August 6, 2012

Page last updated: August 23, 2015

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