Dengue Hemorrhagic Clinical Trial
Official title:
Albumin 5% as Resuscitation in Adult Dengue Fever Patients With Plasma Leakage
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.
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).
Results of randomized translated into a sealed envelope that is not transparent. The number
of envelopes in accordance with the prediction of the number of subjects in each flashlight.
On the outside of the envelope is written flashlight and a number indicating the order of
subject recruitment. Inside the envelope is written the type of fluid to be administered.
This envelope will be opened by investigators with the witness when the subject had to be
given fluid therapy. This procedure will be documented in the minutes of opening the
envelope.
Researchers cooperate with doctors / paramedics at polyclinic and emergency room. Their jobs
are to provide information to the researchers about the patients who infected with dengue
virus proven by NS1 positive test result. Inclusion criteria based on the laboratory test are
lactate ≥ 2.5 mmol/L, increased of haematocrit ≥ 10% but ≤ 15% from base line, and with or
without pleural effusion and or ascites proven by abdominal ultrasound. After the subjects
fulfill these inclusion criteria, researchers will proceed to do the follow-through
assessment.
Subjects are given the explanation about the aim of the research, examination procedures,
therapy, follow-up and side effects which may occur during the research and the benefit of
participating. If the subject or family of subject approves to participate in the research,
they will be given an approval form which is signed before the research conducted.
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