2023-504480-17-00招募中4 期
Clinical impact of pharmacokinetic monitoring of antibiotics in critically ill patients
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2023年7月10日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- - Days of admission to ICU - Days of hospital admission - Days on mechanical ventilation - Days on vasoactive drug treatment - Fever - Biomarkers: procalcitonin and C-reactive protein - SOFA scale. Includes Glasgow scale, oxygen saturation, FIO2, mean arterial pressure, dobutamine use, dopamine dose, noradrenaline dose, daily diuresis (measured on days 1, 3, 7 and end of treatment) - Mortality at 30 days.
研究概览
简要总结
To assess the clinical impact of pharmacokinetic monitoring of antibiotics in the critically ill patient. The following antibiotics are considered in this study: meropenem, cefepime, piperacillin/tazobactam, linezolid and daptomycin.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Cuasi-experimental
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who are candidates for study entry must meet the following criteria (detailed in sections 5.1 Study Type and Design): - Age ≥ 18 years. - Patients admitted to the Intensive Care Unit (ICU) who start treatment with the antibiotics under study and who meet the criteria for inclusion in the intervention or control group (detailed in sections 5.1 Study design). - Intervention group: initiation of treatment during the 48 hours prior to the plasma concentration determination (day and time set weekly). - Control group: start of treatment from the weekly time at which the plasma concentration of the intervention group is determined, until the same number of patients as the intervention group is reached that same week.
排除标准
- •Patients with a duration of antibiotic treatment < 72 hours, have an ICU stay < 48 hours or do not meet the inclusion criteria are excluded.
结局指标
主要结局
- Days of admission to ICU - Days of hospital admission - Days on mechanical ventilation - Days on vasoactive drug treatment - Fever - Biomarkers: procalcitonin and C-reactive protein - SOFA scale. Includes Glasgow scale, oxygen saturation, FIO2, mean arterial pressure, dobutamine use, dopamine dose, noradrenaline dose, daily diuresis (measured on days 1, 3, 7 and end of treatment) - Mortality at 30 days.
- Days of admission to ICU - Days of hospital admission - Days on mechanical ventilation - Days on vasoactive drug treatment - Fever - Biomarkers: procalcitonin and C-reactive protein - SOFA scale. Includes Glasgow scale, oxygen saturation, FIO2, mean arterial pressure, dobutamine use, dopamine dose, noradrenaline dose, daily diuresis (measured on days 1, 3, 7 and end of treatment) - Mortality at 30 days.
次要结局
- Sociodemographics: age, sex, weight, height, medical service (intensive care, coronary unit, anaesthesia).
- Initial clinical data: Charlson index, 10-year survival according to Charlson, presence of relevant comorbidities (diabetes mellitus, heart failure, chronic obstructive pulmonary disease, chronic renal failure, active neoplasia, chronic treatment with corticosteroids, immunosuppressants or chemotherapy, solid organ or haematopoietic progenitor transplant recipients, liver cirrhosis), APACHEII, SAPSII, reason for admission.........
- Treatment data: antibiotic administered (duration of treatment, dosing regimen, dose and time of administration), date and time of antibiotic initiation, antibiotic used previously (only up to the previous day), concomitant anti-infectives used.
- Other analytical variables (day of start of treatment, day 3 and day 7 of treatment and end of treatment): urea, creatinine, bilirubin, aspartate transaminase (AST) and alanine transaminase (ALT) enzymes, alkaline phosphatase (ALP), gamma glutamyl transpeptidase (GGT), creatinine kinase (CK), albumin, haemoglobin, haematocrit, platelets, leukocytes, neutrophils, activated partial thromboplastin time (aPTT) and volume, collection time and urine creatinine if performed during treatment.
- Other clinical data during follow-up: positive cultures (sample, microorganism, sensitivity and MIC if tested), Clostridium difficile toxin detection, water balance, ECMO, ventricular assist or renal replacement therapy (RRT) including duration, type and modality and regimen in case of continuous RRT.
- Intervention data: number of interventions, date and time of intervention, dosing regimen and administration time after intervention, estimated pharmacokinetic parameters (minimum or trough concentration, maximum or peak concentration, area under the 24-hour curve, volume of distribution, half-life).
研究者
UICEC
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
研究点 (1)
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