Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,723
- 试验地点
- 2
- 主要终点
- Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)
研究概览
简要总结
The primary study objective is to assess the rates of blood stream infection (BSI) from the use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital Compounded Bags (HCBs) in patients requiring parenteral nutrition in Spanish hospitals.
详细描述
This is a retrospective observational database study of patients receiving parenteral nutrition (PN) for at least 3 consecutive days with hospital admission date between January 1, 2013, and December 31, 2015 (study period).
The study will use an as treated approach, where patients will be followed from the index date (hospital admission day of the hospitalization during which PN is administered) up to patient discharge or death (observation period).
The study will be conducted using an initial EMR (Electronic Medical Record) data retrieval process, followed by manual data retrieval (chart review) that will complement data obtained from EMR. Data collection for manual data retrieval will be conducted through an eCRF.
The documentation of patient data will comprise two sequential steps. The initial step will include data of 30% of patients and then an interim analysis (IA) will be conducted. If IA shows positive results, data for the remaining 70% of patients (step II) will be gathered.
The study will be conducted in 10-14 sites in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 hospital inpatients ≥ 18 years
- •Treatment with PN for at least 3 consecutive days
- •PN containing all three major macronutrients, delivered from 3CB or HCB
- •Patients with hospital admission between January 1, 2013, and December 31, 2015 (study period)
排除标准
- •Bloodstream infection before or at the same day of first PN administration
- •Immunosuppression due to concomitant therapy (e.g., immunosuppressive therapy due to transplantation, concomitant oral or intravenous administration of glucocorticoids) or disease (e.g., HIV, leukaemia)
- •Permanent vascular access (port, shunts for dialysis)
- •Femoral venous placement of central venous line used for PN
- •Burns, extensive skin injuries (e.g., Lyell´s disease)
- •Chemo-/radiotherapy for up to 3 months before hospital admission
- •Change of PN bag type during observation period, e.g., from HCBs to 3CBs or vice-versa
结局指标
主要结局
Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)
时间窗: Entire study period, from January 1, 2013 and December 31, 2015
Confirmation of BSI required fulfillment of all of the following criteria: * International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32) * Positive blood culture collected during PN administration * Concomitant antimicrobial therapy
次要结局
- Treatment With Antimicrobials During PN(Any day during PN treatment)
- Use of Vasopressor Treatment(Patients requiring vasopressor support at any time during treatment with PN)
- Length of Stay in the ICU(All patients admitted in the ICU at any time during PN treatment)
- Hospital Length of Stay (LOS)(Duration in days from admission to death or discharge for each treatment arm)
- Organ Failure(Any time during PN treatment)
- Sepsis During PN(From date of admission to date of discharge)
- Use of Mechanical Ventilation(Patients requiring mechanical ventilation at any time during PN treatment)
- Renal Replacement Therapy(Patients requiring renal replacement therapy for at least one day during PN treatment)
- Newly-occurred Abnormal Laboratory Findings During PN(During PN treatment inclusive day 1)