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General Surgery Patients at the Intensive Care Unit

Study acronym: TraViII
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Primary completion date: Jan 2027 to Dec 2028
    • Start date: Aug 2025 to Aug 2026
    • Study completion date: Jul 2027 to Jan 2029
    • Publications: details revised at 10 of 10 entries
    v3
  3. Notable Primary completion date: Dec 2025 to Jan 2027
    • Start date: Jan 2025 to Aug 2025
    • Study completion date: Feb 2026 to Jul 2027
    • Publications: details revised at 10 of 10 entries
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU. Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value \<0.05 will be selected as statistical significance. Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality. Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.
Trial Details
NCT Number NCT06731296
Lead Sponsor Hospital Departamental de Villavicencio
Conditions
(from sponsor)
Critical Illness, Postoperative Complications
Related terms Critical Illness, Postoperative Complications
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov