Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

NCT ID: NCT04076254

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-09-30

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.

Conditions

Dengue Hemorrhagic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

albumin

albumin 5%

Group Type: EXPERIMENTAL

Albumins

Intervention Type: DRUG

albumin 5%

fluid

Ringer Lactate

Group Type: ACTIVE_COMPARATOR

Fluid

Intervention Type: DRUG

Ringer Lactate

Interventions

Albumins

albumin 5%

Intervention Type: DRUG

Fluid

Ringer Lactate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Rika Bur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RSAB Harapan Kita

Jakarta, , Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Rika Bur, MD

Role: CONTACT

krekot09@gmail.com

+628129927394

Suhendro Suwarto, MD, Ph.D

Role: CONTACT

suhendro.dr@gmail.com

+628129120617

Facility Contacts

Rika Bur, MD

Role: primary

krekot09@gmail.com

+628129927394

References

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.

Reference Type: DERIVED

PMID: 39350232 (View on PubMed)

Other Identifiers

DEN-09

Identifier Type: -

Identifier Source: org_study_id