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Effects on Microcirculation of IgGAM in Severe Septic/Septic Shock Patients.

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ClinicalTrials.gov Identifier: NCT02655133
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche

Brief Summary:

IgM-enriched immunoglobulins (IgGAM; Pentaglobin ® ) are new therapy for sepsis and septic shock since they support immune system especially in case of " immunoparalysis" . However IgGAM isn't commonly prescribed, few centres use it as routine in severe infections and there aren't any guidelines to determine how and when to use them.

Microcirculatory dysfunction is a crucial aspect in the pathogenesis of sepsis-induced organ dysfunction, resulting in hypoperfusion and tissue hypoxia. Unpublished clinical data suggest a beneficial effect of IgGAM at microvascular level proved with near infrared spectroscopy and Vascular occlusion test (VOT).

This study is a double blind phase II prospective randomised controlled trial that will include patients admitted to the Intensive Care Unit of the University Hospital "Ospedali Riuniti" of Ancona, after no more than 24 hours from development of severe sepsis or septic shoc.

Patients will be randomized into two groups (treaties and controls): patients in group of the treaties will be submitted to infusion of IgGAM conjugate (Pentaglobin ®) at dosage of 250 mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. The controls will receive equal amount of physiological NaCl solution (0.9%) as placebo. Neither the patient nor the staff nurses and MD will be aware of the group and of the treatment applied. IgGAM solutions or NaCl 0.9% will be provided by the hospital pharmacy in similar bags. The remaining treatments will not be changed in any way and will be at the discretion of the doctor who's in charge of the patient. All patients of the two groups will receive the optimal therapy for their conditions, according to good medical clinical practice (GMP), with appropriate antibiotic therapy, vasoactive and infusional therapy


Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: Pentaglobin® Drug: Physiologic solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects on Sublingual Microcirculation of IgGAM Immunoglobulins (Pentaglobin®) in Severe Septic/Septic Shock Patients: a Randomized Controller Trial.
Study Start Date : January 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Pentaglobin®
Patients will receive Immunoglobulins IgGAM (Pentaglobin®) at dosage of 250 mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. Microcirculation will be monitored with sublingual microcirculation device (Cytocam®) and Near InfraRed Specrotcopy (NIRS, Hutchinson®).
Drug: Pentaglobin®
Immunoglobulins that will be used are IgM enriched and will be infused at 5 ml/Kg/day for 3 days.
Other Name: IgGAM

Placebo Comparator: Physiologic Solution
Patients will receive physiologic solution (NaCl 0.9%) at a dosage of 5 ml/Kg per day for 72 hours. Microcirculation will be monitored with sublingual microcirculation device (Cytocam®) and Near InfraRed Specrotcopy (NIRS, Hutchinson®)
Drug: Physiologic solution
Physiologic solution will be infused and will be infused at 5 ml/Kg/day for 3 days.




Primary Outcome Measures :
  1. Perfused vessel density (PVD) [ Time Frame: 72 hours ]
    The perfused vessel density (PVD), unity of measure mm/mm2, is detected in vivo by Incident Dark Field Imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level.


Secondary Outcome Measures :
  1. StO2 upload [ Time Frame: 72 hours ]
    StO2 upslope (%/min) is measured with Near InfraRed Spectroscopy at the tenar muscle. It represents the velocity of the recovery of the tissue oxygen saturation after a short period of ischemia of the hand, the Vascular Occlusion Test.

  2. Microcirculatory Flow Index (MFI) [ Time Frame: 72 hours ]
    Microcirculatory Flow Index detected in vivo by Incident Dark Field Imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level.

  3. Arterial blood lactate [ Time Frame: 72 hours ]
    It represents the level of anaerobic metabolism of the body

  4. SOFA score (Sequential Organ Failure Assessment) [ Time Frame: 72 hours ]
    It represents the organ dysfuntion/failure of each patients



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

Inclusion Criteria:

  • severe sepsis
  • septic shock

Exclusion Criteria:

  • pregnant women
  • severe sepsis/septic shock for more than 24 hours
  • chronic renal failure
  • terminal state with a life expectancy of less than 24 hours
  • contraindications to treatment with IgGAM
  • lack of informed consent will be excluded.

Information from the National Library of Medicine

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): NCT02655133


Locations
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Italy
University ICU, AOU Ospedali Riuniti Ancona
Torrette Di Ancona, Ancona, Italy, 60126
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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Principal Investigator: Abele Donati, MD AOU Ospedali Riuniti di Ancona, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abele Donati, MD, Associate Professor of Anesthesiology, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02655133    
Other Study ID Numbers: IgGAM-CLRZ-2014
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Shock
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation