Dengue FeverNCT05407181
Lymphocyte Count and High Fluorescent Count (HFLC) Correlate With Liver Disorder in Dengue Fever Patients
An observational study of Dengue Fever, run by Nurhasan Agung Prabowo at 2 sites in Indonesia.
Trial summary
Liver dysfunction marked by elevated alanine transaminase enzymes is quite common in dengue patients and subsequently affects the disease's severity and healing process. Unfortunately, liver function tests cannot always be done, especially in hospitals with limited facilities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Blood and Liver Function test
- How many people
- 11 participants
- Where
- 2 sitesIndonesia
- Study dates
- 3 Jun 2022to 5 Jun 2022
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a cross-sectional study involving 11 dengue fever patients, consisting of 9 men and 2 women at Sebelas Maret University Hospital (RS UNS), Sukoharjo.
Who may be able to join
- patients who were hospitalized at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
RS UNS (Universitas Sebelas Maret Hospital)
Sukoharjo, Central Java, 57161
Nurhasan Agung Prabowo, MD, +62 823-2801-0430, dr.nurhasan21@staff.uns.ac.id
Nurhasan Agung Prabowo, MD
- Recruiting
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
Nurhasan Agung Prabowo, MD, +62 823-2801-0430, dr.nurhasan21@staff.uns.ac.id
Nurhasan Agung Prabowo, MD
About this study
Official title: Lymphocyte Count and High Fluorescent Count (HFLC)Correlate With Liver Disorder in Dengue Fever Patients
Liver dysfunction marked by elevated alanine transaminase enzymes is quite common in dengue patients and subsequently affects the disease's severity and healing process. Unfortunately, liver function tests cannot always be done, especially in hospitals with limited facilities. In contrast, routine hematology tests are considered regular and inexpensive tests that can be performed on dengue patients. Therefore, this study aims to determine hematological parameters as markers of elevated liver enzymes in dengue patients.
Read the detailed description
This cross-sectional study involves 11 dengue fever patients, consisting of 9 men and two women, at Sebelas Maret University Hospital (RS UNS), Sukoharjo. The study was conducted in May 2021. Inclusion criteria included patients who were hospitalised at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever. The research was approved by the Regional General Hospital Health Research Ethics Commission (RSUD) by Dr Moewardi Surakarta with the number 938/X/HREC/2021.
Dengue infection is classified according to WHO 2011 criteria, including dengue fever, dengue hemorrhagic fever, and dengue shock syndrome. Dengue fever has criteria in the form of acute fever with two or more other symptoms (headache, retroorbital pain, myalgia, arthralgia, rash, bleeding manifestations); laboratory investigations support dengue fever (platelets 150,000/mm3, leukocytes <5000/mm3, an increase in hematocrit 5-10%), with other confirmed assays (dengue virus isolation; fourfold increase in dengue-specific IgG or IgM serum; antigen or virus detection by immunohistochemistry, immunoassay, and ELISA; genome detection by RT-PCR). Dengue hemorrhagic fever has symptomatic criteria such as dengue fever plus signs and symptoms of plasma leakage (platelets 100,000/mm3, hematocrit increase 20%, pleural effusion, ascites, hypoproteinemia, or hypoalbuminemia). Meanwhile, dengue shock syndrome has symptomatic criteria such as dengue hemorrhagic fever plus symptoms of tachycardia and cold extremities.
Lymphocyte and HFLC examinations were carried out through a haematology analyser's routine blood tests. Meanwhile, liver function tests in aspartate transaminase and alanine transaminase were performed using ELISA. The range of normal cut-off values for each parameter is 11.7-16.2 mg/dL for hemoglobin, 35-45% for hematocrit, 3.9-5.3 x 106/mm3 for erythrocytes, 4.5-11 x 103/mm3 for leukocytes, 150-450 x 103 /mm3 for platelets, 0.8-5 x 103/mm3 for lymphocytes, 1-1.3 for NLR, and 0-1.4 for HFLC.
Data are presented using descriptive statistics and analysed using IBM SPSS (Statistical Package for the Social Sciences) Statistics 25 for Windows 10. Continuous variables are displayed using mean ± SD or median (IQR). Chi-Square tested the relationship between sex data categorical variables. The relationship between continuous variables of haematological parameter data and alanine transaminase status was tested using an unpaired t-test for normally distributed data, a Mann-Whitney test for data that were not normally distributed, and a correlation test in the form of simple logistic regression. The relationship between variables is significant if the p-value <0.05.
- Conditions
- Dengue Fever
- Being tested
- Blood and Liver Function test
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Liver Function testOther
Data was collected through routine blood and liver function tests using a hematology analyzer and ELISA, respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SGPT/ALT with Lymphocytes
Correlation of SGPT/ALT with Lymphocytes
Measured: May 30-June 5 2022
Correlation of SGPT/ALT with HFLC
Correlation of SGPT/ALT with HFLC
Measured: May 30-June 5 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start3 Jun 2022 (estimated)
- Primary completion3 Jun 2022 (estimated)
- Study completion5 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurhasan Agung Prabowo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
- Investigators
- Nurhasan Agung Prabowo, MD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407181
- Sponsor's protocol ID
- DHFandHFLC
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocyte Count and High Fluorescent Count (HFLC)Correlate With Liver Disorder in Dengue Fever Patients
- ClinicalTrials.gov ID
- NCT05407181
- Acronym / sponsor ID
- DHFandHFLC
- Conditions
- Dengue Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Nurhasan Agung PrabowoUniversity, hospital or other
- Study start
- 3 Jun 2022 (estimated)
- Primary completion
- 3 Jun 2022 (estimated)
- Study completion
- 5 Jun 2022 (estimated)
- First posted
- 7 Jun 2022 (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.
Liver dysfunction marked by elevated alanine transaminase enzymes is quite common in dengue patients and subsequently affects the disease's severity and healing process. Unfortunately, liver function tests cannot always be done, especially in hospitals with limited facilities. In contrast, routine hematology tests are considered regular and inexpensive tests that can be performed on dengue patients. Therefore, this study aims to determine hematological parameters as markers of elevated liver enzymes in dengue patients.
Detailed description
This cross-sectional study involves 11 dengue fever patients, consisting of 9 men and two women, at Sebelas Maret University Hospital (RS UNS), Sukoharjo. The study was conducted in May 2021. Inclusion criteria included patients who were hospitalised at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever. The research was approved by the Regional General Hospital Health Research Ethics Commission (RSUD) by Dr Moewardi Surakarta with the number 938/X/HREC/2021.
Dengue infection is classified according to WHO 2011 criteria, including dengue fever, dengue hemorrhagic fever, and dengue shock syndrome. Dengue fever has criteria in the form of acute fever with two or more other symptoms (headache, retroorbital pain, myalgia, arthralgia, rash, bleeding manifestations); laboratory investigations support dengue fever (platelets 150,000/mm3, leukocytes <5000/mm3, an increase in hematocrit 5-10%), with other confirmed assays (dengue virus isolation; fourfold increase in dengue-specific IgG or IgM serum; antigen or virus detection by immunohistochemistry, immunoassay, and ELISA; genome detection by RT-PCR). Dengue hemorrhagic fever has symptomatic criteria such as dengue fever plus signs and symptoms of plasma leakage (platelets 100,000/mm3, hematocrit increase 20%, pleural effusion, ascites, hypoproteinemia, or hypoalbuminemia). Meanwhile, dengue shock syndrome has symptomatic criteria such as dengue hemorrhagic fever plus symptoms of tachycardia and cold extremities.
Lymphocyte and HFLC examinations were carried out through a haematology analyser's routine blood tests. Meanwhile, liver function tests in aspartate transaminase and alanine transaminase were performed using ELISA. The range of normal cut-off values for each parameter is 11.7-16.2 mg/dL for hemoglobin, 35-45% for hematocrit, 3.9-5.3 x 106/mm3 for erythrocytes, 4.5-11 x 103/mm3 for leukocytes, 150-450 x 103 /mm3 for platelets, 0.8-5 x 103/mm3 for lymphocytes, 1-1.3 for NLR, and 0-1.4 for HFLC.
Data are presented using descriptive statistics and analysed using IBM SPSS (Statistical Package for the Social Sciences) Statistics 25 for Windows 10. Continuous variables are displayed using mean ± SD or median (IQR). Chi-Square tested the relationship between sex data categorical variables. The relationship between continuous variables of haematological parameter data and alanine transaminase status was tested using an unpaired t-test for normally distributed data, a Mann-Whitney test for data that were not normally distributed, and a correlation test in the form of simple logistic regression. The relationship between variables is significant if the p-value <0.05.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a cross-sectional study involving 11 dengue fever patients, consisting of 9 men and 2 women at Sebelas Maret University Hospital (RS UNS), Sukoharjo.
Key inclusion criteria (1 listed)
- patients who were hospitalized at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Blood and Liver Function testData was collected through routine blood and liver function tests using a hematology analyzer and ELISA, respectively. | Other | – |
Primary outcome
Correlation of SGPT/ALT with Lymphocytes
Time frame: May 30-June 5 2022
Correlation of SGPT/ALT with Lymphocytes
Correlation of SGPT/ALT with HFLC
Time frame: May 30-June 5 2022
Correlation of SGPT/ALT with HFLC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Nurhasan Agung Prabowo, MD principal investigator
Universitas Sebelas Maret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by Nurhasan Agung Prabowo at 2 sites 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 1 inclusion and 1 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Nurhasan Agung Prabowo, MD (6282328010430, dr.Nurhasan21@staff.uns.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of SGPT/ALT with Lymphocytes (time frame: May 30-June 5 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022.