Dengue HemorrhagicPhase 3NCT04076254
Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever
A Phase 3 study testing Albumins and Fluid in people with Dengue Hemorrhagic, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dengue Hemorrhagic
- What is being tested?
- Albumins and Fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2016to Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSAB Harapan Kita
Jakarta, 11420
Rika Bur, MD, +628129927394, krekot09@gmail.com
About this study
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.
Read the 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.
- Conditions
- Dengue Hemorrhagic
- Being tested
- Albumins, Fluid
- Keywords
- albumin 5%, resuscitation
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminsDrug
albumin 5%
FluidDrug
Ringer Lactate
| Study group | Role | What they receive |
|---|---|---|
| albumin | Experimental | albumin 5% Receives: Drug: Albumins |
| fluid | Active comparator | Ringer Lactate Receives: Drug: Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndecan-1 level
Level of Syndecan-1 in the first 4 hours after fluid resuscitation
Measured: first 4 hour
Syndecan-1 level
Level of Syndecan-1 in the first 12 hours after fluid resuscitation
Measured: first 12 hour
Syndecan-1 level
Level of Syndecan-1 in the first 24 hours after fluid resuscitation
Measured: first 24 hour
Secondary outcomes (6)
haematocrit level
Hematocrit value in the first 4, 12, and 24 hours after fluid resuscitation
Measured: first 4, 12, and 24 hour
platelet count
Platelet count in the first 4, 12, and 24 hours after fluid resuscitation
Measured: first 4, 12, and 24 hour
albumin level
Level of serum albumin in the first 4, 12, and 24 hours after fluid resuscitation
Measured: first 24 and 48 hour
quantitative urinary protein level
Quantitative urinary protein level in the first 24 and 48 hours after fluid resuscitation
Measured: first 24 and 48 hour
lactate level
Serum lactate level in the first 12 and 24 hours after fluid resuscitation
Measured: first 12 and 24 hour
length of hospital stay
Patients' length of hospital stay through study completion
Measured: throughout study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study startOct 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue HemorrhagicStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rika Bur, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076254
- Sponsor's protocol ID
- DEN-09
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2016
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bur R, Suwarto S, Pohan HT, Prihartono J, Harahap AR, Dewi BE, Sadikin M, Rachman A, Yusuf H. Early intervention of 5% albumin shown superior control of vascular integrity and function compared to ringer's lactatein hospitalized adult with grade I & II Dengue hemorrhagic fever: a multicenter randomized controlled trial in Indonesia. Trop Dis Travel Med Vaccines. 2024 Oct 1;10(1):20. doi: 10.1186/s40794-024-00230-3.
PubMed 39350232
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin 5% as Resuscitation in Adult Dengue Fever Patients With Plasma Leakage
- ClinicalTrials.gov ID
- NCT04076254
- Acronym / sponsor ID
- DEN-09
- Conditions
- Dengue Hemorrhagic
- Keywords
- albumin 5%, resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| albumin | Experimental | Drug: Albuminsalbumin 5% |
| fluid | Active comparator | Drug: FluidRinger Lactate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuminsalbumin 5% | Drug | albumin |
| FluidRinger Lactate | Drug | fluid |
Primary outcome
Syndecan-1 level
Time frame: first 4 hour
Level of Syndecan-1 in the first 4 hours after fluid resuscitation
Syndecan-1 level
Time frame: first 12 hour
Level of Syndecan-1 in the first 12 hours after fluid resuscitation
Syndecan-1 level
Time frame: first 24 hour
Level of Syndecan-1 in the first 24 hours after fluid resuscitation
6 secondary outcomes
haematocrit level
Time frame: first 4, 12, and 24 hour
platelet count
Time frame: first 4, 12, and 24 hour
albumin level
Time frame: first 24 and 48 hour
quantitative urinary protein level
Time frame: first 24 and 48 hour
lactate level
Time frame: first 12 and 24 hour
length of hospital stay
Time frame: throughout study completion, an average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 39350232Bur R, Suwarto S, Pohan HT, Prihartono J, Harahap AR, Dewi BE, Sadikin M, Rachman A, Yusuf H. Early intervention of 5% albumin shown superior control of vascular integrity and function compared to ringer's lactatein hospitalized adult with grade I & II Dengue hemorrhagic fever: a multicenter randomized controlled trial in Indonesia. Trop Dis Travel Med Vaccines. 2024 Oct 1;10(1):20. doi: 10.1186/s40794-024-00230-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumins and Fluid in people with Dengue Hemorrhagic, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rika Bur, MD (+628129927394, krekot09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syndecan-1 level (time frame: first 4 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.