Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT) : a randomised, blinded, placebo-controlled trial. / Madsen, Martin B.; Hjortrup, Peter B.; Hansen, Marco B.; Lange, Theis; Norrby-Teglund, Anna; Hyldegaard, Ole; Perner, Anders.
I: Intensive Care Medicine, Bind 43, Nr. 11, 11.2017, s. 1585-1593.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT)
T2 - a randomised, blinded, placebo-controlled trial
AU - Madsen, Martin B.
AU - Hjortrup, Peter B.
AU - Hansen, Marco B.
AU - Lange, Theis
AU - Norrby-Teglund, Anna
AU - Hyldegaard, Ole
AU - Perner, Anders
PY - 2017/11
Y1 - 2017/11
N2 - 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.
AB - 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.
KW - Fournier's gangrene
KW - Necrotising fasciitis
KW - Patient-reported outcome measure
KW - Quality of life
KW - Sepsis
KW - SF-36
U2 - 10.1007/s00134-017-4786-0
DO - 10.1007/s00134-017-4786-0
M3 - Journal article
C2 - 28421246
VL - 43
SP - 1585
EP - 1593
JO - European Journal of Intensive Care Medicine
JF - European Journal of Intensive Care Medicine
SN - 0935-1701
IS - 11
ER -
ID: 185228187