Impact of Early Peri-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery
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ClinicalTrials.gov Identifier: NCT01646229 |
Recruitment Status
:
Completed
First Posted
: July 20, 2012
Last Update Posted
: May 13, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Abdominal Sepsis Peritonitis Colon Perforation | Other: Polymyxin-B hemoperfusion Other: Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Impact of Early Per-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | February 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Polymyxin-B hemoperfusion
In the HEMOPERFUSION group, a veno-venous dialysis catheter type GamCath 12 F, 3 lumen will be inserted instead of a regular double or triple-lumen central venous catheter, and connected to the Toraymyxin® (PMX-20-R) device for endotoxin adsorption by hemoperfusion with the DECAPSMART pump. The length of the hemoperfusion will be a minimum of 120 min and started just before the beginning of the surgical intervention in the OR and stopped at the end of surgery.
|
Other: Polymyxin-B hemoperfusion |
Active Comparator: Control
In the CONTROL group, the administration of fluids (250 to 500ml crystalloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP between > 8 and 12 < mmHg, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mMol/L, normalisation of the BE. At the discretion of the attending anaesthesiologist with the FMH level, a PiCCO monitoring, a transoesophageal echography, or a pulmonary artery catheter, will be inserted to complement the standard hemodynamic monitoring if deemed necessary. |
Other: Control |
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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 ]
- 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 ]
- The secondary endpoint will be the 90-days mortality [ Time Frame: The 90-days mortality will be assessed on day 90 post PMX hemoperfusion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646229
Switzerland | |
Emergency operating room, Geneva Cantonal Hospital | |
Geneva, Switzerland, 1211 |
Study Director: | Jerome Pugin, Professor | Hôpitaux Universitaires de Genève |
Responsible Party: | Pavlovic Gordana, MD, Principal Investigator, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT01646229 History of Changes |
Other Study ID Numbers: |
NAC11-054(CC11-146) |
First Posted: | July 20, 2012 Key Record Dates |
Last Update Posted: | May 13, 2016 |
Last Verified: | May 2016 |
Keywords provided by Pavlovic Gordana, MD, University Hospital, Geneva:
Hemoperfusion Polymyxin-B Emergency abdominal surgery Sepsis Endotoxin |
Additional relevant MeSH terms:
Sepsis Peritonitis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Intraabdominal Infections |
Peritoneal Diseases Digestive System Diseases Polymyxins Polymyxin B Anti-Bacterial Agents Anti-Infective Agents |