Dengue FeverPrediDengueNCT04422782
New Tools for Predicting Capillary Leak Shock During Dengue Fever
A study testing For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine in people with Dengue Fever and Children, run by Centre Hospitalier de Cayenne at 1 site in France.
Trial summary
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Dengue Fever, Children, Adults
- What is being tested?
- For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2020to 14 May 2023
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age> = 5 years
- Patient / parent consent
- Exclude other pathology with capillary circulation problem (septic shock, anaphylaxis) All suspected dengue fever requiring hospitalization will be included, final inclusion being after biological confirmation (AgNS1, RT-PCR, serology).
Who cannot join
- Age <5 years
- Refusal to participate
- Unsigned consent
- Coinfection by another agent
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
General Hospital of Cayenne
Cayenne, French Guiana, 97306
Mathieu Nacher, MD, PhD, 0594395024 ext. 5024, mathieu.nacher@ch-cayenne.fr
About this study
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.
Read the detailed description
On the South American continent, dengue fever progressively progresses to hyperendemia with co-circulation of different serotypes. Among the complications of dengue fever, a frequent complication is the shock linked to capillary leakage which often occurs at the time of defervescence between the 3rd or 5th day of evolution of the fever. Before that, it is difficult to identify patients who are at risk for severe forms. Patients are therefore seen regularly to monitor for the development of serious forms, which causes saturation of the health system. Despite everything, with each epidemic, the investigators observe deaths of previously healthy people, which always constitutes an important trauma for the population and for the carers. Improving the understanding of the pathophysiology of capillary leakage and the tools to predict it would be significant advances in this common tropical pathology. Thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it possible to generate precise hypotheses as to the pathophysiology of the shock linked to capillary leakage. Hypoprotidemia and hyponatremia having a strong statistical association with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of the plasma osmolarity resulting in water leaks towards the interstitial sector.
These preliminary data also made it possible to develop a predictive score which must now be validated over time.
Research involving the human person, monocentric, prospective, validation
Interventional research protocol involving the human person category 2 at risk and minimal constraints
- Conditions
- Dengue Fever, Children, Adults
- Being tested
- For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
- Keywords
- Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia, Hypoprotidemia, Clinical-biological score, Interstitial fluid
- Medical subject headings
- Dengue, Shock, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urineOther
Also called Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue, Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant
Interventional research protocol involving the human person category 2 at risk and minimal constraints
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm Receives: Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a shock
The primary outcome measure will be the occurrence of a shock defined by systolic blood pressure <90 mm Hg in adults and <80 mm Hg in children.
Measured: 2 years
Secondary outcomes (6)
Predictive value of plasma hypo-osmolarity
Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
Measured: 2 years
Validation of the clinical-biological prognostic score
Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it
Measured: 2 years
Relationship between the measurements obtained by osmolarity and capillary leakage
Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion
Measured: 2 years
Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage
Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion
Measured: 2 years
How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
Measured: 2 years
Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Study the association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start14 May 2020
- Primary completion14 May 2022 (estimated)
- Study completion14 May 2023 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Mathieu NACHER, MD, PhD, Study director, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422782
- Sponsor's protocol ID
- PrediDengue
- Acronym
- PrediDengue
- Status last verified
- Dec 2020
- First submitted
- 5 Jun 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.
PubMed 28938048
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tools for Predicting Capillary Leak Shock During Dengue Fever
- ClinicalTrials.gov ID
- NCT04422782
- Acronym / sponsor ID
- PrediDengue / PrediDengue
- Conditions
- Dengue Fever, Children, Adults
- Keywords
- Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- European Regional Development Fund
- Study start
- 14 May 2020 (actual)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 14 May 2023 (estimated)
- First posted
- 9 Jun 2020 (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.
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.
Detailed description
On the South American continent, dengue fever progressively progresses to hyperendemia with co-circulation of different serotypes. Among the complications of dengue fever, a frequent complication is the shock linked to capillary leakage which often occurs at the time of defervescence between the 3rd or 5th day of evolution of the fever. Before that, it is difficult to identify patients who are at risk for severe forms. Patients are therefore seen regularly to monitor for the development of serious forms, which causes saturation of the health system. Despite everything, with each epidemic, the investigators observe deaths of previously healthy people, which always constitutes an important trauma for the population and for the carers. Improving the understanding of the pathophysiology of capillary leakage and the tools to predict it would be significant advances in this common tropical pathology. Thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it possible to generate precise hypotheses as to the pathophysiology of the shock linked to capillary leakage. Hypoprotidemia and hyponatremia having a strong statistical association with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of the plasma osmolarity resulting in water leaks towards the interstitial sector.
These preliminary data also made it possible to develop a predictive score which must now be validated over time.
Research involving the human person, monocentric, prospective, validation
Interventional research protocol involving the human person category 2 at risk and minimal constraints
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urineSingle Arm |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age> = 5 years
- Patient / parent consent
- Exclude other pathology with capillary circulation problem (septic shock, anaphylaxis) All suspected dengue fever requiring hospitalization will be included, final inclusion being after biological confirmation (AgNS1, RT-PCR, serology).
Key exclusion criteria (5 listed)
- Age <5 years
- Refusal to participate
- Unsigned consent
- Coinfection by another agent
- Patient under guardianship or curatorship.
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 |
|---|---|---|
| For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urineAlso: Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue, Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrantInterventional research protocol involving the human person category 2 at risk and minimal constraints | Other | Single Arm |
Primary outcome
Occurrence of a shock
Time frame: 2 years
The primary outcome measure will be the occurrence of a shock defined by systolic blood pressure <90 mm Hg in adults and <80 mm Hg in children.
6 secondary outcomes
Predictive value of plasma hypo-osmolarity
Time frame: 2 years
Validation of the clinical-biological prognostic score
Time frame: 2 years
Relationship between the measurements obtained by osmolarity and capillary leakage
Time frame: 2 years
Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage
Time frame: 2 years
How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
Time frame: 2 years
Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 28938048Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.
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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.
Mathieu NACHER, MD, PhD study director
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine in people with Dengue Fever and Children, run by Centre Hospitalier de Cayenne at 1 site in France.
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 5 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 10 Dec 2020. 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 France. 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 Felix DJOSSOU, MD (0594395040 ext. +594, felix.djossou@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a shock (time frame: 2 years). 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 NCT04422782, 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 10 Dec 2020.