Clinical Trial: Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Brief Summary: The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

Detailed Summary:

Patients with necrotizing soft tissue infections (NSTI) receive intravenous polyspecific immunoglobulin G (IVIG) as part of the standard treatment at Rigshospitalet. The current evidence available does not support neither the use of IVIG, nor omitting it, as adjuvant treatment of NSTI. With this trial the investigators will estimate the effects of IVIG on a patient-reported outcome and other important outcomes in patients with NSTI

Design A randomized, double-blinded, clinical trial where patients are randomly assigned 1:1 to receive either IVIG or an equal volume of 0.9% saline.

Location A single centre trial conducted at Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet.

Randomisation Randomisation will be stratified according to primary presentation of NSTI on the extremities/head/neck (yes/no) as streptococci mainly affect these anatomical sites. Two randomisation lists, with varying block size, are generated. Two separate boxes contain sequentially numbered, opaque, sealed envelopes (SNOSE). Two people independent of the trial will generate the envelopes following the randomisation lists and will document that the envelopes are concordant with the randomisation lists. Staff at trial site will have access to the boxes around the clock, and will draw an envelope containing a patient randomisation- and medicine log document assigned either "Privigen" or "Saline" from one of the two boxes.

Intervention Trial medicine is given when the patient arrives at the ICU and the following two consecutive days. Alternatively, the first dose of trial medicine will be given in the operating theatre.The trial medicine will consist of either IVIG 25 g/day (250 ml) (Privigen, CSL Behring) or a
Sponsor: Anders Perner

Current Primary Outcome: Physical Component Summary Score (PCS) of Short-Form 36 (SF-36) [ Time Frame: Six months after randomisation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 28, 90 and 180 days ]
  • Time to resolution of shock [ Time Frame: During ICU admission (expected average of 8 days) ]
    Maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for 24 hours
  • Severe bleeding [ Time Frame: During ICU admission (expected average of 8 days) ]
    Clinical bleeding and use of 3 units of red blood cells (RBCs) within 24 hours at any time in the ICU
  • Any bleeding in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
  • Use of blood products [ Time Frame: During ICU admission ]
    Total volumes during the ICU admission
  • SOFA scores (AUC), excluding the Glasgow Coma Score (GCS) score [ Time Frame: Day 1-7 ]
  • Use of renal replcement therapy (RRT), ventilation and vasopressor in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
  • Days alive off life support in the 90 days after randomisation [ Time Frame: 90 days after randomisation ]
  • Days alive and out of hospital in the 180 day follow-up period [ Time Frame: 180 day follow-up period ]
  • Amputation, any location [ Time Frame: Within 180 days ]
  • Serious Adverse Reactions (SARs) in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
    • Allergic reactions
    • Haemolytic anaemia
    • Aseptic meningitis syndrome
    • Thrombus
    • Transmittable agents
    • Acute kidney injury


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: April 3, 2014
Date Started: April 2014
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016