Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Difference in the NYHA score between d-15 and d4 after treatment initiation
研究概览
简要总结
Pneumonia is the second common infection and its risk increases for elderly. In this population, it is the first cause of mortality by infections, and source of many complications. Geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. It is well known that vitamin C is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin C, and for one of those studies it was noted a significant reduction of mortality. The main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.
详细描述
This study is French non-comparative phase II clinical trial, double-blind randomized, with placebo, single-center. One group would be treated the placebo group, and another would receive an adjuvant treatment by vitamin C : 500 mg twice a day by intra-venous way from the first day to the second included, and then 500 mg twice a day by oral way from the third day to the seventh. For each patient, the study's duration is 7 days, which is the mean stay of hospitalization. During those 7 days, we will make clinical exams and blood tests at d0, d2, d4 and d7. The vitamin C blood level will be measured at d0 and d7.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people aged ≥ 75 years old
- •pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de Langue Française) :
- •at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at the auscultation
- •at least one general sign suggesting an infection : fever, sweat, headache, sore joints, common cold
- •pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included
排除标准
- •palliative care's patients
- •patients with deglutition's disorders
- •patients who can't be on a drip
- •antibiotherapy since more one day
- •other concomitant infection(s)
- •patients who can't make their own transfer 15 days ago
- •patients who have a NYHA score at IV 15 days ago
- •patients with contraindication to a vitamin C treatment : hemochromatosis, oxalo-calcic lithiasis antecedent, G6PD deficit (Glucose 6 Phosphate Dehydrogenase), and treatment by Deferoxamine
研究组 & 干预措施
Placebo
Each patient of this group will be received a direct intravenous injection of 2,5 ml NaCl 9% twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, mannitol's capsules produced by the University Hospital Bordeaux's central pharmacy will be given at patient at the morning and at the lunchtime.
干预措施: Placebo (Drug)
Vitamin C
Each patient of this group will be received a direct intravenous injection of 2,5 ml ascorbic acid twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, ascorbic acid's capsules produced by the University Hospital Bordeaux's central pharmacy to keep the double blind way of this study will be given at patient at the morning and at the lunchtime.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Difference in the NYHA score between d-15 and d4 after treatment initiation
时间窗: 4 days after randomisation/treatment initiation
The NYHA score d-15 would be noted by medical staff at the inclusion by calling the patient's general practitioner. The NYHA score at d4 will be noted by investigators treating the patient.
次要结局
- The NYHA score at d2 and d7(2 and 7 days after randomisation/treament initiation)
- Blood saturation without oxygen therapy at d2, d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Katz's ADL (Activities Daily Living) score at d2,d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Blood inflammation parameters at d2,d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Vitamin C blood level at d7(7 days after randomisation/treament initiation)
- Dyspnea's visual analogic scale at d2, d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Asthenia's evaluation at d2,d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Possibility for the patient to make his or her own transfer at d2,d4 and d7(2, 4 and 7 days after randomisation/treament initiation)
- Morbidity-mortality at d2,d4 and d7(2, 4 and 7 days after randomisation/treament initiation)