Albumin 5% as Resuscitation in Adult Dengue Fever Patients With Plasma Leakage
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Syndecan-1 level
研究概览
简要总结
Endothelial cell had important role in plasma leakage process. Plasma leakage occurs due to increased vascular permeability caused by disruption of endothelial glycocalyx showed by increased syndecan-1 level in serum. Endothelial vascular permeability disruption may cause several clinical manifestations such as increased haematocrit level, pleural effusion, ascites, hypoalbuminemia, thrombocytopenia, and bleeding manifestation. This condition will lead to hypoperfusion in the tissue and microvascular dysfunction. Microvascular dysfunction activated anaerob mechanism and resulting increased lactate level serum. Severe dysfunction can lead to shock and death if fluid resuscitation is inadequate in the first 24 hour.
Fluid administration becomes key therapy for plasma leakage. Crystalloid is an isotonic fluid which can fill intravascular, however this fluid also quickly moved toward extravascular. Albumin 5% can help reduce the extravasation because of it can increase the osmotic pressure and maintaining the intravascular volume. In the first 24 hour after albumin administration, albumin is hypothesized can restore intravascular volume, repair and maintain glycocalyx, maintain vascular permeability, and restore microcirculation perfusion. This mechanisms can prevent worse outcome and hoped can reduce hospital stay.
Many studies had been done regarding the choice of resuscitation fluid in septic patient. Until now, the role of albumin 5% as resuscitation fluid in DHF to prevent severe plasma leakage has not been studied.
详细描述
This study is an open label randomized control trial with concealment procedure which is to compare the effect of albumin 5% and ringer lactate towards plasma leakage incidence in adult DHF patient. This clinical trial cannot be done in double blind because it is technically impossible.
This study was conducted in dengue fever patients who were treated in internal medicine wards in RSUD Tangerang Selatan and RSAB Harapan Kita. Recruitment starts from October 2016 to February 2017.
The target population of this research is all adult dengue virus infected patients that were hospitalized in the hospital. Accessible population are all dengue fever patients who were treated in internal medicine wards in RSUD Tangerang Selatan and RSAB Harapan Kita from October 2016 to February 2017. Subject is accessible population that met the inclusion criteria.
All subjects who met the inclusion criteria were included in the study by consecutive sampling.
The subject allocation was done by a third party using randomized block by software WINPEPI, with the same number of subjects in each block. Randomization process will be stratified according to study sites (RSUD Tangerang Selatan and RSAB Harapan Kita).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 and ≤ 60 years
- •Patients with a history of fever ≤ 3 days, with NS1 positive, and diagnosed with DHF which marked by plasma leakage in microvascular that characterized by lactate levels ≥ 2.5 mmol / L and increased haematocrit ≥ 10% but ≤15 % of initial haematocrit. And may or not be accompanied by the presence of pleural effusion or ascites in abdominal ultrasound.
- •Patients are hospitalized at RSUD Tangerang Selatan, RS Hermina Ciputat, RSUD Cengkareng,RSUD Taman Sari, RSUD Kembangan, and RS Royal Taruma from January 2018 to February 2019.
排除标准
- •Patients who are pregnant and confirmed by tests β HCG, or in menstruation cycle.
- •Patients with comorbid diseases such as metabolic syndrome, liver cirrhosis, sepsis, renal disorders, hematological disorders, immunocompromised, and malnutrition.
- •Refuse to participate in the study.
研究组 & 干预措施
albumin
albumin 5%
干预措施: Albumins (Drug)
fluid
Ringer Lactate
干预措施: Fluid (Drug)
结局指标
主要结局
Syndecan-1 level
时间窗: first 24 hour
Level of Syndecan-1 in the first 24 hours after fluid resuscitation
次要结局
- haematocrit level(first 4, 12, and 24 hour)
- quantitative urinary protein level(first 24 and 48 hour)
- lactate level(first 12 and 24 hour)
- length of hospital stay(throughout study completion, an average of 5 days)
- platelet count(first 4, 12, and 24 hour)
- albumin level(first 24 and 48 hour)
研究者
Rika Bur
Principal Investigator
Indonesia University