Severe Dengue in Critical Care at Villavicencio, Colombia.
NCT ID: NCT05938647
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-07-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
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.
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
120 Years
ALL
No
Sponsors
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Cooperative University of Colombia
OTHER
Hospital Departamental de Villavicencio
OTHER
Responsible Party
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Norton Perez-Gutierrez, MD
Principal investigator
Principal Investigators
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Norton Perez-Gutierrez, MD
Role: PRINCIPAL_INVESTIGATOR
Cooperative University of Colombia
Locations
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Clinica Primavera
Villavicencio, Meta Department, Colombia
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, Colombia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GRIVI_2023_02_DENGUE
Identifier Type: -
Identifier Source: org_study_id
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