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Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

Primary Purpose

Dengue Hemorrhagic

Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Albumins
Fluid
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dengue Hemorrhagic focused on measuring albumin 5%, resuscitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RSAB Harapan KitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

albumin

fluid

Arm Description

albumin 5%

Ringer Lactate

Outcomes

Primary Outcome Measures

Syndecan-1 level
Level of Syndecan-1 in the first 4 hours after fluid resuscitation
Syndecan-1 level
Level of Syndecan-1 in the first 12 hours after fluid resuscitation
Syndecan-1 level
Level of Syndecan-1 in the first 24 hours after fluid resuscitation

Secondary Outcome Measures

haematocrit level
Hematocrit value in the first 4, 12, and 24 hours after fluid resuscitation
platelet count
Platelet count in the first 4, 12, and 24 hours after fluid resuscitation
albumin level
Level of serum albumin in the first 4, 12, and 24 hours after fluid resuscitation
quantitative urinary protein level
Quantitative urinary protein level in the first 24 and 48 hours after fluid resuscitation
lactate level
Serum lactate level in the first 12 and 24 hours after fluid resuscitation
length of hospital stay
Patients' length of hospital stay through study completion

Full Information

First Posted
October 31, 2016
Last Updated
August 30, 2019
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04076254
Brief Title
Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever
Official Title
Albumin 5% as Resuscitation in Adult Dengue Fever Patients With Plasma Leakage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Hemorrhagic
Keywords
albumin 5%, resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
albumin
Arm Type
Experimental
Arm Description
albumin 5%
Arm Title
fluid
Arm Type
Active Comparator
Arm Description
Ringer Lactate
Intervention Type
Drug
Intervention Name(s)
Albumins
Intervention Description
albumin 5%
Intervention Type
Drug
Intervention Name(s)
Fluid
Intervention Description
Ringer Lactate
Primary Outcome Measure Information:
Title
Syndecan-1 level
Description
Level of Syndecan-1 in the first 4 hours after fluid resuscitation
Time Frame
first 4 hour
Title
Syndecan-1 level
Description
Level of Syndecan-1 in the first 12 hours after fluid resuscitation
Time Frame
first 12 hour
Title
Syndecan-1 level
Description
Level of Syndecan-1 in the first 24 hours after fluid resuscitation
Time Frame
first 24 hour
Secondary Outcome Measure Information:
Title
haematocrit level
Description
Hematocrit value in the first 4, 12, and 24 hours after fluid resuscitation
Time Frame
first 4, 12, and 24 hour
Title
platelet count
Description
Platelet count in the first 4, 12, and 24 hours after fluid resuscitation
Time Frame
first 4, 12, and 24 hour
Title
albumin level
Description
Level of serum albumin in the first 4, 12, and 24 hours after fluid resuscitation
Time Frame
first 24 and 48 hour
Title
quantitative urinary protein level
Description
Quantitative urinary protein level in the first 24 and 48 hours after fluid resuscitation
Time Frame
first 24 and 48 hour
Title
lactate level
Description
Serum lactate level in the first 12 and 24 hours after fluid resuscitation
Time Frame
first 12 and 24 hour
Title
length of hospital stay
Description
Patients' length of hospital stay through study completion
Time Frame
throughout study completion, an average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rika Bur, MD
Phone
+628129927394
Email
krekot09@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suhendro Suwarto, MD, Ph.D
Phone
+628129120617
Email
suhendro.dr@gmail.com
Facility Information:
Facility Name
RSAB Harapan Kita
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rika Bur, MD
Phone
+628129927394
Email
krekot09@gmail.com

12. IPD Sharing Statement

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Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

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