Resuscitation With Albumin 5% in Dengue Haemorrhagic Fever

NCT04076254 | Unknown Phase 3 DMC

• 1 other identifier: DEN-09
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue Hemorrhagic

Keywords

albumin 5%; resuscitation

Outcome Measures

Primary Outcomes (3)

• Syndecan-1 level

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

  first 4 hour

• Syndecan-1 level

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

  first 12 hour

• Syndecan-1 level

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

  first 24 hour

Secondary Outcomes (6)

• haematocrit level

  first 4, 12, and 24 hour

• platelet count

  first 4, 12, and 24 hour

• albumin level

  first 24 and 48 hour

• quantitative urinary protein level

  first 24 and 48 hour

• lactate level

  first 12 and 24 hour

Study Arms (2)

albumin

EXPERIMENTAL

albumin 5%

Drug: Albumins

fluid

ACTIVE COMPARATOR

Ringer Lactate

Drug: Fluid

Interventions

Albumins DRUG

albumin 5%

albumin

Fluid DRUG

Ringer Lactate

fluid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSAB Harapan Kita

Jakarta, 11420, Indonesia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39350232 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Albumins; Fluid Therapy

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Drug Therapy; Therapeutics

Central Study Contacts

Rika Bur, MD

CONTACT

+628129927394; krekot09@gmail.com

Suhendro Suwarto, MD, Ph.D

CONTACT

+628129120617; suhendro.dr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: September 3, 2019
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

ID (1)