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

Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646229
• Other study ID #: NAC11-054(CC11-146)
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Sepsis
• Colon Perforation
• Peritonitis
• Sepsis

Intervention

Other:
• Polymyxin-B hemoperfusion

• Control

Locations

Country	Name	City	State
Switzerland	Emergency operating room, Geneva Cantonal Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be requirement of vasopressors during the first 72 hrs after the beginning of the PMX hemoperfusion using the "inotropic score"		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	The secondary endpoint will be the variation of MAP, during the first 72 hrs after the beginning of the PMX hemoperfusion		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	The secondary endpoint will be the variation of "vasopressor dependency index", during the first 72 hrs after the beginning of the PMX hemoperfusion		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.
Secondary	The secondary endpoint will be the variation of Pa02/Fi02, during the first 72 hrs after the beginning of the PMX hemoperfusion		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.
Secondary	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 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
Secondary	The secondary endpoint will be the 28-days mortality		The 28-days mortality will be assessed on the 28th day post PMX hemoperfusion
Secondary	The secondary endpoint will be the 90-days mortality		The 90-days mortality will be assessed on day 90 post PMX hemoperfusion