Severe Dengue in Critical Care at Villavicencio, Colombia.

Severe Dengue Clinical Trial

Official title:

Characteristics of Patients With Severe Dengue Admitted in Critical Care Units at Villavicencio, Colombia. A Retrospective Observational Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938647
• Other study ID #: GRIVI_2023_02_DENGUE
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Hospital Departamental de Villavicencio
• Contact: Norton Perez-Gutierrez, MD
• Phone: 6086660154
• Email: norton.perez[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Severe dengue is a cause of admission to critical care, especially in pediatric cases, and during epidemic outbreaks. Fluid support is basically the therapy offered, due to a scarcity of antiviral or immunological options to modulate the disease. Dengue is an endemic condition in tropical and subtropical regions as Villavicencio, and local ICUs provide care to the adult and pediatric population from the city and distant surrounding areas. National and international agencies' clinical guidelines have standard recommendations for the therapy of dengue shock syndrome (DSS), but data about performance is not available. Severity, organ dysfunction, hemorrhagic events, and capillary leak are predictors for decease. There are several epidemiological trials about dengue in the region, although publications about the characteristics of patients in ICU are nearly null. Currently, there is enough human resources and technology in ICU to provide an optimal care in cases of severe dengue. There is a need to recognize most appropriate strategies for the treatment of the disease, and their results, to adjust and provide better outcomes.

The aim of the study is to analyze the characteristics of patients with severe dengue admitted to the intensive care unit, to contribute to knowledge and better understanding of the disease in a specific clinical environment.

An observational retrospective study will be designed by the analysis of the ICU database of hospitals from Villavicencio, Colombia, since January to May 2023. The records of patients admitted with a diagnose of severe dengue will be exported to Excel for reviewing and debugging. Demographic information, laboratory results, severity scores, and outcomes will be examined. Categorical variables will be described by frequency and proportion; quantitative variables will be defined in a central and dispersion distribution. Chi-square and Mann-Whitney U test will be used to compare, according to the characteristics of the outcome.

It will be a pioneer study at this region, and it is necessary to determine the characteristics of patients admitted to the intensive care unit, the care provided, and the results of the treatment.

Description:

Dengue is an endemic viral infection in tropical and subtropical regions like Colombia, with epidemic outbreaks every three years, with severity especially in pediatric cases. Clinical symptoms, and signs are the fundamental strategies for the diagnosis, although they are not explicit for the disease, so it can be undetected. No specific antiviral therapy is available yet.

An increase in the vascular permeability is observed in severe cases. Some viral, and individual characteristics are recognized as risk factors for severity. Viral serotype, secondary infection, comorbidities, and individual genetic host factors predispose to a hyperinflammatory stage and increased response to the infection.

About 5% of severe cases have risk of mortality. Early detection of warning signs, hydration and appropriate care is crucial to prevent decease, and severe cases require proper attention in an ICU for monitoring, fluid restoration, and support of organ dysfunction.

Aggressive fluid therapy is proposed by national and international health organisms, based and limited trials. Crystalloids initial boluses and high fluid therapy are recommended to counter capillary leakage. It involves a risk of fluid overload with chances of secondary injury as pulmonary edema, tissue hypoperfusion, and organ disfunction.

Personalized monitoring of fluid therapy is necessary to achieve the goals of therapy, replacing fluid loss, but reducing timely the accumulated balance. ICU admission offers the opportunity to accomplish such a goal by adjusting the clinical practice guidelines to individual and dynamic needs, based in scientific evidence.

Several publications have evaluated strategies of fluid therapy in sepsis and shock, considering four overlapping phases (ROSE): resuscitation; optimization; stabilization; and evacuation. None of the studies have evaluated patients with dengue.

Determining the characteristics of patients admitted to the ICU by severe dengue, will provide essential information of severity, the therapy provided, the type of support delivered, and the outcomes attained. It will improve the knowledge about the accomplishment of clinical practice guidelines and its results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

• Patients admitted at a critical care unit with a diagnose of dengue either clinical or by a positive serology or molecular diagnostic methods.

Exclusion Criteria:

• Patients with a post admission diagnosis different than dengue either clinical or by a negative serology.

Related Conditions & MeSH terms

• Dengue
• Severe Dengue

Intervention

Other:
• Risk factor: group 3
Severe dengue, no shock. No diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.
• Risk factor: group 4
Dengue shock syndrome. No diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes

Locations

Country	Name	City	State
Colombia	Clinica Primavera	Villavicencio	Meta
Colombia	Hospital Departamental de Villavicencio	Villavicencio	Meta

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Departamental de Villavicencio	Cooperative University of Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (12)

Chen CM, Chan KS, Yu WL, Cheng KC, Chao HC, Yeh CY, Lai CC. The outcomes of patients with severe dengue admitted to intensive care units. Medicine (Baltimore). 2016 Aug;95(31):e4376. doi: 10.1097/MD.0000000000004376. — View Citation

Gupta S, Gupta M, Kashyap JR, Arora SK. Early cardiovascular involvement in dengue fever: A prospective study with two-dimensional speckle tracking echocardiography. Trop Doct. 2022 Apr;52(2):285-292. doi: 10.1177/00494755221076686. Epub 2022 Jan 31. — View Citation

Madanayake P, Jayawardena A, Wijekoon SL, Perera N, Wanigasuriya J. Fluid requirement in adult dengue haemorrhagic fever patients during the critical phase of the illness: an observational study. BMC Infect Dis. 2021 Mar 20;21(1):286. doi: 10.1186/s12879- — View Citation

McBride A, Vuong NL, Van Hao N, Huy NQ, Chanh HQ, Chau NTX, Nguyet NM, Ming DK, Ngoc NT, Nhat PTH, Phong NT, Tai LTH, Tho PV, Trung DT, Tam DTH, Trieu HT, Geskus RB, Llewelyn MJ, Thwaites CL, Yacoub S. A modified Sequential Organ Failure Assessment score — View Citation

Rosenberger KD, Alexander N, Martinez E, Lum LCS, Dempfle CE, Junghanss T, Wills B, Jaenisch T; DENCO Clinical Study Group. Severe dengue categories as research endpoints-Results from a prospective observational study in hospitalised dengue patients. PLoS — View Citation

Sachdev A, Pathak D, Gupta N, Simalti A, Gupta D, Gupta S, Chugh P. Early Predictors of Mortality in Children with Severe Dengue Fever: A Prospective Study. Pediatr Infect Dis J. 2021 Sep 1;40(9):797-801. doi: 10.1097/INF.0000000000003179. — View Citation

Sengupta SP, Nugurwar A, Jaju R, Khandheria BK. Left ventricular myocardial performance in patients with dengue hemorrhagic fever and thrombocytopenia as assessed by two-dimensional speckle tracking echocardiography. Indian Heart J. 2013 May-Jun;65(3):276 — View Citation

Suwarto S, Nainggolan L, Sinto R, Effendi B, Ibrahim E, Suryamin M, Sasmono RT. Dengue score: a proposed diagnostic predictor for pleural effusion and/or ascites in adults with dengue infection. BMC Infect Dis. 2016 Jul 8;16:322. doi: 10.1186/s12879-016-1 — View Citation

Swamy AM, Mahesh PY, Rajashekar ST. Liver function in dengue and its correlation with disease severity: a retrospective cross-sectional observational study in a tertiary care center in Coastal India. Pan Afr Med J. 2021 Dec 23;40:261. doi: 10.11604/pamj.2 — View Citation

Thanachartwet V, Desakorn V, Sahassananda D, Jittmittraphap A, Oer-Areemitr N, Osothsomboon S, Surabotsophon M, Wattanathum A. Serum Procalcitonin and Peripheral Venous Lactate for Predicting Dengue Shock and/or Organ Failure: A Prospective Observational — View Citation

Trieu HT, Khanh LP, Ming DKY, Quang CH, Phan TQ, Van VCN, Deniz E, Mulligan J, Wills BA, Moulton S, Yacoub S. The compensatory reserve index predicts recurrent shock in patients with severe dengue. BMC Med. 2022 Apr 7;20(1):109. doi: 10.1186/s12916-022-02 — View Citation

Yacoub S, Trung TH, Lam PK, Thien VHN, Hai DHT, Phan TQ, Nguyet OPK, Quyen NTH, Simmons CP, Broyd C, Screaton GR, Wills B. Cardio-haemodynamic assessment and venous lactate in severe dengue: Relationship with recurrent shock and respiratory distress. PLoS — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of ICU days	Length of ICU stay	30 days
Other	Number of hospital days	Length of hospitalization	30-days
Other	Number of participants with mechanical ventilation	Need of mechanical ventilation	30-days
Other	Number of days in mechanical ventilation	Length of mechanical ventilation	30-days
Primary	Number of deaths	Hospital death	30-days
Secondary	Amount of fluid accumulation	Daily positive fluid balance	5 days