ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)
关键词
抽象
描述
The project will consist of a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial, with PROBE design (Prospective Randomized Open Trial with Blinded Evaluation of Outcomes), in patients with septic shock, as defined according to clinical criteria.
Patients will be randomized in a 1:1:1:1 ratio to one of the 4 study groups (Albumin + BAL, Albumin + NS, BAL, NS).
Both the primary endpoints will include events evaluated objectively: 90-day mortality and incidence of AKI, as assessed by KDIGO criteria (KDIGO Acute Kidney Injury Work Group, 2012).
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 08/02/2018 |
| 提交的预估入学人数: | 08/28/2018 |
| 首次发布: | 08/30/2018 |
| 上次提交的更新: | 12/03/2019 |
| 最近更新发布: | 12/04/2019 |
| 实际学习开始日期: | 05/06/2019 |
| 预计主要完成日期: | 12/30/2020 |
| 预计完成日期: | 02/27/2022 |
状况或疾病
干预/治疗
Biological: Albumin
Other: Balanced
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Albumin + Balanced Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination.
Balanced crystalloid solutions
According to the preference and the standard use of the participating center:
Ringer Lactate
Ringer Acetate
Crystalsol | |
| Experimental: Albumin + Saline Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination.
Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl). | |
| Experimental: Balanced Balanced crystalloid solutions (Ringer Lactate, Ringer Acetate, Crystalsol) | |
| No Intervention: Saline Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Patients with septic shock if they meet the two following criteria: 1. Presence of an infection (known or suspected) in at least one site: 1. Lung 2. Abdomen 3. Urinary tract 4. Others (blood, skin and soft tissues, central nervous system, bones and joints, cardiac system, reproductive organs). 2. Presence of a severe and acute, sepsis-related cardiovascular failure (as assessed by the SOFA score - see Annex 1), requiring vasopressor to maintain mean arterial pressure >=65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score > 2 (3 or 4) If the patient is unable to provide informed consent, she/he can be included in the trial provided that the requirements of ongoing laws are fulfilled; details on this approach are provided in the protocol, par 11.1 and related Annex 3. The patient will be informed about having been included in a clinical trial, as soon as she/he will regain consciousness. Exclusion Criteria: 1. Age < 18 years 2. Moribund state 3. Known or suspected adverse reaction to albumin administration 4. Septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected) 5. Severe congestive heart failure (NYHA III and IV classes) 6. Clinical situations in which the use of albumin is known or supposed to be clinically beneficial (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing enteropathy, nephrotic syndrome, burns) 7. More than 24 hours after the onset of septic shock 8. Religious objection to the administration of human blood products 9. Presence of chronic end-stage renal disease 10. Severe hyperkalemia 11. Enrollment in other experimental interventional studies |
结果
主要结果指标
1. All-cause 90-day mortality [Up to 90 days]
2. Combined co-primary endpoint [Up to 90 days]
次要成果指标
1. ICU mortality [Up to ICU discharge, a median of 9 days]
2. In-hospital mortality [Up to hospital discharge, a median of 20 days]
3. 1-year mortality [Up to 1 year]
4. SOFA score [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
5. Incidence of AKI [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
6. RRT [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
7. Need for vasopressors [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
8. Mechanical ventilation [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
9. Secondary infections in ICU [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
10. Duration of stay in ICU [Up to ICU discharge, a median of 9 days]
11. Duration of stay in hospital [Up to hospital discharge, a median of 20 days]
其他成果措施
1. Severe metabolic acidosis [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
2. Severe hyperkalemia [Up to 90 days or ICU discharge - a median of 9 days - whichever comes first]
