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Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

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ClinicalTrials.gov Identifier: NCT04076254
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rika Bur, Indonesia University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dengue Hemorrhagic Drug: Albumins Drug: Fluid Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Albumin 5% as Resuscitation in Adult Dengue Fever Patients With Plasma Leakage
Study Start Date : October 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: albumin
albumin 5%
Drug: Albumins
albumin 5%

Active Comparator: fluid
Ringer Lactate
Drug: Fluid
Ringer Lactate




Primary Outcome Measures :
  1. Syndecan-1 level [ Time Frame: first 4 hour ]
    Level of Syndecan-1 in the first 4 hours after fluid resuscitation

  2. Syndecan-1 level [ Time Frame: first 12 hour ]
    Level of Syndecan-1 in the first 12 hours after fluid resuscitation

  3. Syndecan-1 level [ Time Frame: first 24 hour ]
    Level of Syndecan-1 in the first 24 hours after fluid resuscitation


Secondary Outcome Measures :
  1. haematocrit level [ Time Frame: first 4, 12, and 24 hour ]
    Hematocrit value in the first 4, 12, and 24 hours after fluid resuscitation

  2. platelet count [ Time Frame: first 4, 12, and 24 hour ]
    Platelet count in the first 4, 12, and 24 hours after fluid resuscitation

  3. albumin level [ Time Frame: first 24 and 48 hour ]
    Level of serum albumin in the first 4, 12, and 24 hours after fluid resuscitation

  4. quantitative urinary protein level [ Time Frame: first 24 and 48 hour ]
    Quantitative urinary protein level in the first 24 and 48 hours after fluid resuscitation

  5. lactate level [ Time Frame: first 12 and 24 hour ]
    Serum lactate level in the first 12 and 24 hours after fluid resuscitation

  6. length of hospital stay [ Time Frame: throughout study completion, an average of 5 days ]
    Patients' length of hospital stay through study completion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged ≥ 18 and ≤ 60 years
  2. 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.
  3. 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.

Exclusion Criteria:

  1. Patients who are pregnant and confirmed by tests β HCG, or in menstruation cycle.
  2. Patients with comorbid diseases such as metabolic syndrome, liver cirrhosis, sepsis, renal disorders, hematological disorders, immunocompromised, and malnutrition.
  3. Refuse to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076254


Contacts
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Contact: Rika Bur, MD +628129927394 krekot09@gmail.com
Contact: Suhendro Suwarto, MD, Ph.D +628129120617 suhendro.dr@gmail.com

Locations
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Indonesia
RSAB Harapan Kita Recruiting
Jakarta, Indonesia, 11420
Contact: Rika Bur, MD    +628129927394    krekot09@gmail.com   
Sponsors and Collaborators
Indonesia University
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Responsible Party: Rika Bur, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04076254    
Other Study ID Numbers: DEN-09
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Keywords provided by Rika Bur, Indonesia University:
albumin 5%
resuscitation
Additional relevant MeSH terms:
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Dengue
Severe Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral