Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- The proportion of clinical stable patients at day 5, measured from hospital admission.
研究概览
简要总结
Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain.
This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.
详细描述
This project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. The estimated sample size is of 360 patients, who will be recruited from three Spanish hospitals. Hypoalbuminemic (≤30g/L) adult patients with CAP will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone.
The primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat.
The secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality.
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
- 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
- •Age ≥ 18 years.
- •Diagnosis of CAP (Chest radiography consistent with CAP AND the presence of ≥2 following prespecified clinical criteria: Fever or hypothermia; Cough; Purulent sputum; High white blood cell count; Dyspnea; Pleuritic chest pain; Signs consistent with pneumonia on chest auscultation)
- •Serum albumin concentration ≤ 30 g/L at presentation
排除标准
- •Pregnancy or lactation
- •Immunosuppression (e.g. chemotherapy or radiotherapy within 90 days, immunosuppressive drugs, corticosteroids at a minimum dose of 15mg/day of prednisone within 2 weeks of enrolment, HIV with a CD4 count below 200, solid organ transplant recipients, hematopoietic cell transplant recipients).
- •Severe clinical status with expected survival of less than 24h.
- •Congestive heart failure (New York Heart Association classes 3 or 4)
- •Any contraindication for albumin administration such as hypersensitivity to albumin.
- •Clinical conditions in which there is another indication for albumin administration (e.g. hepatic cirrhosis with ascites, malabsorption syndrome and nephrotic syndrome).
- •Absence or impossibility of obtaining informed consent from the patient/next of kin.
- •Patient already included in another clinical trial testing a treatment method.
研究组 & 干预措施
Standard care plus albumin
Patients will receive human albumin 20%, 20g in 100ml (Albutein Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08015 Barcelona, Spain) intravenously every 12 hours for 4 days or until death, discharge or clinical stability if occurring before.
Patients will receive empirical antibiotic therapy according to guidelines as soon as CAP is confirmed. All microbiological assessments and additional treatment (e.g. oxygen, bronchodilators, corticosteroids, analgesic drugs, vasoactive agents, fluid resuscitation, and mechanical ventilation) will be at the discretion of the treating physicians (not the study investigators). The time of discharge and duration of antibiotics will not be determined by the study investigators, but by the treating physician team.
干预措施: Albumin Human (Drug)
结局指标
主要结局
The proportion of clinical stable patients at day 5, measured from hospital admission.
时间窗: Day 5±1 of hospitalization
Clinical stability will be defined as achieving normal oral intake, normal mental status (or usual level of functioning) and stable vital signs for at least 24 h, as previously described by Halm et al 1998
次要结局
- The rate of nosocomial infection during hospitalization(Up to hospital discharge - a median of 10 days)
- Proportion of adverse events.(Up to 30 ±5 days after discharge)
- The number of patients with hospital readmission within 30 days of discharge(Up to 30 ±5 days after discharge)
- All-cause mortality(Up to 30 ±5 days after discharge)
- Time to clinical stability (days) measured from hospital admission(Up to 30 ±5 days after discharge)
- Duration of intravenous and total antibiotic treatment (days).(Up to 30 ±5 days after discharge)
- Length of hospital stay (days).(Up to hospital discharge - a median of 10 days)
- Proportion of patients with intensive care unit (ICU) admission.(Up to hospital discharge - a median of 10 days)
研究者
Jordi Carratala
Sponsor
Hospital Universitari de Bellvitge