Evidence map›Paper›PMID 28421246›Full record

Trial reportIntensive care medicine2017

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

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Intensive care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02111161 (Immunoglobulin for Necrotizing Soft Tissue Infections), which is not on this map. Cited by 55 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 3 pooled it
8.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02111161 phase2completednot on this map

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

TypeinterventionalSponsorAnders PernerRan2014 to 2016Enrolled100ConditionsNecrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene, Fournier GangreneArmsIVIG (Privigen), Saline 0.9%
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Interventions for necrotizing soft tissue infections in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Top unanswered questions in antimicrobial management of necrotizing soft tissue infections.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2026
    Review
  12. Characteristics, treatments, and outcomes of patients with necrotizing soft tissue infections: a Dutch multicenter cohort study.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025
    Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Complicated and deep bacterial skin and soft tissue infections.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 3 countries.

Martin B MadsenDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Peter B HjortrupDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Marco B HansenDepartment of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Theis LangeDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Anna Norrby-TeglundCentre for Infectious Medicine, Karolinska Institutet, Karolinska University Hospital, Huddinge, Sweden.
Ole HyldegaardDepartment of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. anders.perner@regionh.dk.
Copenhagen University Hospital · DKKarolinska Institutet · SEPeking University · CNRigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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).

methodsWe 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).

resultsOf 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.

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

trial registrationNCT02111161.

Indexed as

Acute Kidney InjuryAgedCritical CareDouble-Blind MethodFemaleHumansImmunoglobulins, IntravenousImmunologic FactorsInfusions, IntravenousIntensive Care UnitsIntention to Treat AnalysisMaleMiddle AgedNecrosisQuality of LifeSelf ReportImmunoglobulins, IntravenousImmunologic FactorsFournier’s gangreneNecrotising fasciitisPatient-reported outcome measureQuality of lifeSepsisSF-36

Identifiers

PMID28421246
OpenAlexW2607400732

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.