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Adjunctive IgM-enriched immunoglobulin therapy with a personalised dose based on serum IgM-titres versus standard dose in the treatment of septic shock: a randomised controlled trial (IgM-fat trial).
Biagioni, Emanuela; Tosi, Martina; Berlot, Giorgio; Castiglione, Giacomo; Corona, Alberto; De Cristofaro, Maria Giovanna; Donati, Abele; Feltracco, Paolo; Forfori, Francesco; Fragranza, Fiorentino; Murino, Patrizia; Piazza, Ornella; Tullo, Livio; Grasselli, Giacomo; D'Amico, Roberto; Girardis, Massimo.
  • Biagioni E; Anesthesia and Intensive Care, University Hospital Modena, Modena, Emilia-Romagna, Italy.
  • Tosi M; Anesthesia and Intensive Care, University Hospital Modena, Modena, Emilia-Romagna, Italy.
  • Berlot G; Anesthesia and Intensive Care Unit, Major Hospital of Trieste, Trieste, Friuli-Venezia Giulia, Italy.
  • Castiglione G; Anesthesia and Intensive Care Unit, University Hospital Vittorio Emanuele Catania Polyclinic, Catania, Sicilia, Italy.
  • Corona A; Anesthesia and Intensive Care Unit, Luigi Sacco University Hospital, Milano, Lombardia, Italy.
  • De Cristofaro MG; Anesthesia and Intensive Care Unit, Antonio Cardarelli Hospital, Napoli, Campania, Italy.
  • Donati A; Anesthesia and Intensive Care Unit, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Umberto I G M Lancisi G Salesi, Ancona, Marche, Italy.
  • Feltracco P; Anesthesia and Intensive Care Unit, Azienda Ospedaliera di Padova, Padova, Veneto, Italy.
  • Forfori F; Anesthesia and Intensive Care Unit, Pisa University Hospital, Pisa, Toscana, Italy.
  • Fragranza F; Anesthesia and Intensive Care Unit, Cotugno Hospital, Napoli, Campania, Italy.
  • Murino P; Anesthesia and Intensive Care Unit, Monaldi Hospital, Napoli, Campania, Italy.
  • Piazza O; Anesthesia and Intensive Care Unit, University of Salerno, Fisciano, Campania, Italy.
  • Tullo L; Anesthesia and Intensive Care Unit, Foggia University Hospital, Foggia, Puglia, Italy.
  • Grasselli G; Anesthesia and Intensive Care Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy.
  • D'Amico R; Medical and Surgical Science, University Hospital Modena, Modena, Emilia-Romagna, Italy.
  • Girardis M; Anesthesia and Intensive Care, University Hospital Modena, Modena, Emilia-Romagna, Italy girardis.massimo@unimo.it.
BMJ Open ; 11(2): e036616, 2021 02 11.
Article in English | MEDLINE | ID: covidwho-1228874
Semantic information from SemMedBD (by NLM)
1. Adjuvant Therapy TREATS Septic Shock
Subject
Adjuvant Therapy
Predicate
TREATS
Object
Septic Shock
2. Septic Shock PROCESS_OF Patients
Subject
Septic Shock
Predicate
PROCESS_OF
Object
Patients
3. Additional Therapy PROCESS_OF Patients
Subject
Additional Therapy
Predicate
PROCESS_OF
Object
Patients
4. Immunoglobulins AFFECTS Immune response
Subject
Immunoglobulins
Predicate
AFFECTS
Object
Immune response
5. Immunoglobulins ASSOCIATED_WITH Septicemia
Subject
Immunoglobulins
Predicate
ASSOCIATED_WITH
Object
Septicemia
6. Emilia LOCATION_OF NDNF gene|NDNF
Subject
Emilia
Predicate
LOCATION_OF
Object
NDNF gene|NDNF
7. Adjuvant Therapy TREATS Septic Shock
Subject
Adjuvant Therapy
Predicate
TREATS
Object
Septic Shock
8. Septic Shock PROCESS_OF Patients
Subject
Septic Shock
Predicate
PROCESS_OF
Object
Patients
9. Additional Therapy PROCESS_OF Patients
Subject
Additional Therapy
Predicate
PROCESS_OF
Object
Patients
10. Immunoglobulins AFFECTS Immune response
Subject
Immunoglobulins
Predicate
AFFECTS
Object
Immune response
11. Immunoglobulins ASSOCIATED_WITH Septicemia
Subject
Immunoglobulins
Predicate
ASSOCIATED_WITH
Object
Septicemia
12. Emilia LOCATION_OF NDNF gene|NDNF
Subject
Emilia
Predicate
LOCATION_OF
Object
NDNF gene|NDNF
ABSTRACT

INTRODUCTION:

In patients with septic shock, low levels of circulating immunoglobulins are common and their kinetics appear to be related to clinical outcome. The pivotal role of immunoglobulins in the host immune response to infection suggests that additional therapy with polyclonal intravenous immunoglobulins may be a promising option in patients with septic shock. Immunoglobulin preparations enriched with the IgM component have largely been used in sepsis, mostly at standard dosages (250 mg/kg per day), regardless of clinical severity and without any dose adjustment based on immunoglobulin serum titres or other biomarkers. We hypothesised that a personalised dose of IgM enriched preparation based on patient IgM titres and aimed to achieve a specific threshold of IgM titre is more effective in decreasing mortality than a standard dose. METHODS AND

ANALYSIS:

The study is designed as a multicentre, interventional, randomised, single-blinded, prospective, investigator sponsored, two-armed study. Patients with septic shock and IgM titres <60 mg/dL will be randomly assigned to an IgM titre-based treatment or a standard treatment group in a ratio of 11. The study will involve 12 Italian intensive care units and 356 patients will be enrolled. Patients assigned to the IgM titre-based treatment will receive a personalised daily dose based on an IgM serum titre aimed at achieving serum titres above 100 mg/dL up to discontinuation of vasoactive drugs or day 7 after enrolment. Patients assigned to the IgM standard treatment group will receive IgM enriched preparation daily for three consecutive days at the standard dose of 250 mg/kg. The primary endpoint will be all-cause mortality at 28 days. ETHICS AND DISSEMINATION The study protocol was approved by the ethics committees of the coordinating centre (Comitato Etico dell'Area Vasta Emilia Nord) and collaborating centres. The results of the trial will be published within 12 months from the end of the study and the steering committee has the right to present them at public symposia and conferences. TRIAL REGISTRATION DETAILS The trial protocol and information documents have received a favourable opinion from the Area Vasta Emilia Nord Ethical Committee on 12 September 2019. The trial protocol has been registered on EudraCT (2018-001613-33) on 18 April 2018 and on ClinicalTrials.gov (NCT04182737) on 2 December 2019.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Shock, Septic / COVID-19 Type of study: Controlled clinical trial / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2019-036616

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Shock, Septic / COVID-19 Type of study: Controlled clinical trial / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2019-036616