Intensive Care Medicine

, Volume 43, Issue 11, pp 1585–1593 | Cite as

Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial

  • Martin B. Madsen
  • Peter B. Hjortrup
  • Marco B. Hansen
  • Theis Lange
  • Anna Norrby-Teglund
  • Ole Hyldegaard
  • Anders Perner
Seven-Day Profile Publication

Abstract

Purpose

The aim of the INSTINCT trial was to assess the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo on self-reported physical function in intensive care unit (ICU) patients with necrotising soft tissue infection (NSTI).

Methods

We randomised 100 patients with NSTI 1:1 to masked infusion of 25 g of IVIG (Privigen, CSL Behring) or an equal volume of 0.9% saline once daily for the first 3 days of ICU admission. The primary outcome was the physical component summary (PCS) score of the 36-item short form health survey (SF-36) 6 months after randomisation; patients who had died were given the lowest possible score (zero).

Results

Of the 100 patients randomised, 87 were included in the intention-to-treat analysis of the PCS score, 42 patients (84%) in the IVIG group and 45 patients (90%) in the placebo group. The two intervention groups had similar baseline characteristics with the exception of IVIG use before randomisation (1 dose was allowed) and rates of acute kidney injury. Median PCS scores were 36 (interquartile range 0–43) in the group assigned to IVIG and 31 (0–47) in the group assigned to placebo (mean adjusted difference 1 (95% confidence interval −7 to 10), p = 0.81). The result was supported by analyses adjusted for baseline prognostics, those in the per protocol populations, in the subgroups (site of NSTI) and those done post hoc adjusted for IVIG use before randomisation.

Conclusions

In ICU patients with NSTI, we observed no apparent effects of adjuvant IVIG on self-reported physical functioning at 6 months.

Trial registration: NCT02111161.

Keywords

Fournier’s gangrene Necrotising fasciitis Patient-reported outcome measure Quality of life Sepsis SF-36 

Supplementary material

134_2017_4786_MOESM1_ESM.pdf (541 kb)
Supplementary material 1 (PDF 541 kb)
134_2017_4786_MOESM2_ESM.pdf (504 kb)
Supplementary material 2 (PDF 504 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2017

Authors and Affiliations

  • Martin B. Madsen
    • 1
  • Peter B. Hjortrup
    • 1
  • Marco B. Hansen
    • 2
  • Theis Lange
    • 3
    • 4
  • Anna Norrby-Teglund
    • 5
  • Ole Hyldegaard
    • 2
  • Anders Perner
    • 1
  1. 1.Department of Intensive CareCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
  2. 2.Department of Anaesthesia, Centre of Head and OrthopaedicsCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
  3. 3.Department of Public Health, Section of BiostatisticsUniversity of CopenhagenCopenhagenDenmark
  4. 4.Centre for Statistical SciencePeking UniversityBeijingChina
  5. 5.Centre for Infectious Medicine, Karolinska InstitutetKarolinska University HospitalHuddingeSweden

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