Efficacy and Safety of OctaplasLG® Administration vs. Crystalloids (Standard) in Patients With Septic Shock - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Microscan at 24 hours
研究概览
简要总结
Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial
详细描述
This is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase IIa trial in patients with septic shock investigating the efficacy and safety of administrating OctaplasLG® as compared to crystalloids, such as Ringer-Acetate (standard of care) in a total of 40 patients.
40 patients will be enrolled:
- Patients in the active treatment group (n = 20 patients) will receive OctaplasLG® as volume support according to trial algorithm.
- Patients in the standard of care group (n = 20 patients) will receive crystalloids, such as Ringer-Acetate, as volume support according to trial algorithm.
All patients will be treated according to the standard ICU care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult intensive care patients (age ≥ 18 years) AND
- •Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
- •Quick SOFA (qSOFA) with two or more of
- •Respiratory rate ≥ 22/min
- •Altered mentation (Glasgow Coma Scale score < 15)
- •Systolic blood pressure ≤ 100mmHg AND
- •Septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation AND
- •Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
- •Respiratory failure requiring intubation and mechanical ventilation
排除标准
- •Documented refusal of blood transfusion OR
- •Treatment with GPIIb/IIIa inhibitors < 24h from screening OR
- •Withdrawal from active therapy OR
- •Previously within 30 days included in an interventional trial OR
- •Known IgA deficiency with documented antibodies against IgA OR
- •Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100)) OR
- •Known severe deficiencies of protein S OR
- •Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
- •Severe cirrhotic hepatic failure with expected need for treatment with terlipressin
研究组 & 干预措施
OctaplasLG
OctaplasLG® is an industrial donor plasma product pooled from 630 -1520 single donor units. It possesses unique features when compared to standard FFP, such as having a standardized concentration of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen-free.12 Most importantly, the manufacturing method of OctaplasLG® removes immune complexes and cells in several steps of microfiltration. The manufacturing process also inactivates viral, bacterial and prion pathogen by immune neutralization, solvent-detergent treatment and a prion specific ligand affinity chromatography step.
干预措施: OctaplasLG (Drug)
Ringer-Acetate
standard of care resuscitation fluid Ringer-acetate is a mixture of electrolytes in water to a slightly hypotonic solution.
干预措施: Ringer-Acetate (Drug)
结局指标
主要结局
Microscan at 24 hours
时间窗: 24 hours after baseline
Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique.
Biomarkers at 24 hours
时间窗: 24 hours after baseline
Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion.
次要结局
- 7 day mortality(7 days after inclusion)
- Renal Replacement Therapy(For the first 7 days after inclusion)
- 24 hour mortality(24 hours after inclusion)
- Days on vasopressors(Days, assessed at 30-days and 90-days)
- Days on ventilator(Days, assessed at 30-days and 90-days)
- Transfusion requirements(For the first 7 days after inclusion)
- 30 day mortality(30 days after inclusion)
- Length of stay in the ICU(Days, assessed at 30-days and 90-days)
- 90 day mortality(90 days after inclusion)
- Serious Adverse Reactions at 72 hours(For the first 72 hours after inclusion)
- Serious Adverse Reactions at day 30(At day 30 after inclusion)
- Oxygenation(At 24 hours, 48 hours, 72 hours and at day 7 after baseline)
- RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease(For the first 7 days in the ICU)
研究者
Jakob Stensballe, MD, PhD
Consultant Anaethetist, MD, PhD
Rigshospitalet, Denmark