Severe Dengue in Critical Care at Villavicencio, Colombia.

NCT05938647 | Completed

• 1 other identifier: GRIVI_2023_02_DENGUE
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Severe Dengue

Outcome Measures

Primary Outcomes (1)

• Number of deaths

  Hospital death

  30-days

Secondary Outcomes (1)

• Amount of fluid accumulation

  5 days

Other Outcomes (4)

• Number of ICU days

  30 days

• Number of hospital days

  30-days

• Number of participants with mechanical ventilation

  30-days

Study Arms (2)

Dengue hemorrhagic fever group 3

Risk factor (severity 3): no diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.

Other: Risk factor: group 3

DHF group 4 (DSS);

Risk factor (group 4): no diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.

Other: Risk factor: group 4

Interventions

Risk factor: group 3 OTHER

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.

Dengue hemorrhagic fever group 3

Risk factor: group 4 OTHER

Dengue shock syndrome. No diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes

DHF group 4 (DSS);

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants in the trial are those patients treated in a critical care unit for dengue during the period of study, according to the registers of admission in the institution.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Departamental de Villavicencio: lead
• Cooperative University of Colombia: collaborator

Study Sites (2)

Clinica Primavera

Villavicencio, Meta Department, 50001, Colombia

Location

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related 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.

  PMID: 27495047 RESULT

• 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.

  PMID: 35098804 RESULT

• 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/s12879-021-05971-6.

  PMID: 33743614 RESULT

• 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 for dengue: development, evaluation and proposal for use in clinical trials. BMC Infect Dis. 2022 Sep 3;22(1):722. doi: 10.1186/s12879-022-07705-8.

  PMID: 36057771 RESULT

• 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 Negl Trop Dis. 2020 Mar 4;14(3):e0008076. doi: 10.1371/journal.pntd.0008076. eCollection 2020 Mar.

  PMID: 32130212 RESULT

• 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.

  PMID: 34321449 RESULT

• 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):276-82. doi: 10.1016/j.ihj.2013.04.017. Epub 2013 Apr 9.

  PMID: 23809381 RESULT

• 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/s12879-016-1671-3.

  PMID: 27391122 RESULT

• 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.2021.40.261.29795. eCollection 2021.

  PMID: 35251455 RESULT

• 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 Study. PLoS Negl Trop Dis. 2016 Aug 26;10(8):e0004961. doi: 10.1371/journal.pntd.0004961. eCollection 2016 Aug.

  PMID: 27564863 RESULT

• 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/s12916-022-02311-6.

  PMID: 35387649 RESULT

• 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 Negl Trop Dis. 2017 Jul 10;11(7):e0005740. doi: 10.1371/journal.pntd.0005740. eCollection 2017 Jul.

  PMID: 28692675 RESULT

MeSH Terms

Conditions

Severe Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

• Norton Perez-Gutierrez, MD

  Cooperative University of Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 20, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CO (2)