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NCT Number: NCT01646229

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

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.

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Key information

Conditions

Abdominal Sepsis Colon Perforation Digestive System Diseases Infections Inflammation Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency operating room, Geneva Cantonal Hospital

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymyxin-B hemoperfusion

Other

Control

Other

Primary outcomes

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

    Time frame: The inotropic score is assessed at the following specific time points: Time 0 - baseline measurements at the beginning of surgery, second time point at the end of surgery, Time 0 +6 hours, Time 0 + 24 hours, Time 0 + 48 hours, Time 0 + 72 hours.

Secondary outcomes

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

    Time frame: The inotropic score is assessed at the following specific time points: Time 0 - baseline measurements at the beginning of surgery, second time point at the end of surgery, Time 0 +6 hours, Time 0 + 24 hours, Time 0 + 48 hours, Time 0 + 72 hours.

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

    Time frame: The variation of the "vasopressor dependency index" is assessed at: Time 0 - baseline measurements at the beginning of surgery, second time point at the end of surgery, Time 0 +6 hours, Time 0 + 24 hours, Time 0 + 48 hours, Time 0 + 72 hours.

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

    Time frame: The variation of Pa02/Fi02 is assessed at the following specific time points: Time 0 - baseline measurements at the beginning of surgery, second time point at the end of surgery, Time 0 +6 hours, Time 0 + 24 hours, Time 0 + 48 hours, Time 0 + 72 hours.

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

    Time frame: The variations of the total SOFA score will be assessed once a day from day 1, till discharge of the ICU, and this maximaly 7 days after the beginning of the PMX hemoperfusion

  5. The secondary endpoint will be the 28-days mortality

    Time frame: The 28-days mortality will be assessed on the 28th day post PMX hemoperfusion

  6. The secondary endpoint will be the 90-days mortality

    Time frame: The 90-days mortality will be assessed on day 90 post PMX hemoperfusion

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 20, 2012
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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