Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Physical Component Summary Score (PCS) of Short-Form 36 (SF-36)
研究概览
简要总结
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).
详细描述
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 an equal volume of 0.9% saline. The dosage of IVIG is 25g/day for three consecutive days for all patients, which is according to the clinical protocol at Rigshospitalet. The treatment will be given according to the clinical protocol for Privigen at Rigshospitalet. The treating clinicians will decide all other interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Necrotizing soft tissue infection (NSTI) based on surgical findings
- •Age >18 years
- •Admitted to or planned to be admitted to the ICU at Rigshospitalet (RH)
排除标准
- •>48 hour from the primary diagnosis to arrival at RH
- •More than one dose of IVIG given within current admission
- •Known hypersensitivity to IVIG
- •Hyperprolinaemia (obtained from hospital notes)
- •Pregnancy or breast feeding
研究组 & 干预措施
IVIG (Privigen)
Intravenous polyspecific immunoglobulin G (Privigen). Dosage: 25 g/day (250 ml) for three consecutive days
干预措施: IVIG (Privigen) (Drug)
Saline 0.9%
0.9% saline for Intravenous administration. Dosage: 250 ml for three consecutive days.
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Physical Component Summary Score (PCS) of Short-Form 36 (SF-36)
时间窗: Six months after randomisation
次要结局
- Any bleeding in the ICU(During ICU admission (expected average of 8 days))
- Use of blood products(During ICU admission)
- SOFA scores (AUC), excluding the Glasgow Coma Score (GCS) score(Day 1-7)
- Mortality(28, 90 and 180 days)
- Time to resolution of shock(During ICU admission (expected average of 8 days))
- Severe bleeding(During ICU admission (expected average of 8 days))
- Use of renal replcement therapy (RRT), ventilation and vasopressor in the ICU(During ICU admission (expected average of 8 days))
- Days alive off life support in the 90 days after randomisation(90 days after randomisation)
- Days alive and out of hospital in the 180 day follow-up period(180 day follow-up period)
- Amputation, any location(Within 180 days)
- Serious Adverse Reactions (SARs) in the ICU(During ICU admission (expected average of 8 days))
研究者
Anders Perner
MD, PhD, Professor
Rigshospitalet, Denmark