Identification of Vitamin C Deficiency in Hospitalized Adults Through a Systematic Approach Vs. Traditional Medical Judgment: a Before-and-After Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.
研究概览
简要总结
Brief Summary of the Study The goal of this observational study is to assess the incidence of vitamin C deficiency among hospitalized adults presenting with hemorrhagic signs. The study will also evaluate the effectiveness of a standardized screening protocol compared to traditional clinical judgment.
The main questions it aims to answer are:
What is the incidence of vitamin C deficiency in hospitalized patients with hemorrhagic symptoms? Is a standardized screening protocol more effective than traditional clinical judgment in identifying vitamin C deficiency? Is vitamin C deficiency associated with anemia, other micronutrient deficiencies (folate, B12, albumin, iron), or infectious conditions? Does vitamin C deficiency impact hospital length of stay? Researchers will compare a systematic screening approach based on predefined hemorrhagic criteria (e.g., hematuria, ecchymosis, epistaxis, petechiae, gastrointestinal bleeding, or intracranial hemorrhage) to the traditional physician-judgment approach to determine its effectiveness in identifying vitamin C deficiency.
Study Design
Participants will:
Be hospitalized adults (≥18 years old) presenting with documented micro- or macroscopic hemorrhagic signs.
Undergo vitamin C level assessment either as part of the standardized screening protocol (prospective arm) or based on physician judgment (retrospective control group).
Have additional clinical and laboratory data collected, including hemoglobin levels, platelet count, iron status, vitamin B9/B12 levels, and other relevant parameters.
This non-interventional study will not modify the standard of care but will systematically assess the prevalence of vitamin C deficiency in at-risk patients and evaluate the utility of a structured screening protocol.
详细描述
Study Design and Methodology
Study Type:
Observational (before-after study design)
Retrospective for the control group (patients with historical vitamin C measurements) and for exposure group (patients systematically screened based on predefined hemorrhagic criteria)
Study Population:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adult patients (≥18 years old) who had Vitamin C testing performed during their hospital stay.
- •Documented hemorrhagic manifestations in medical records, including at least one of the following:
- •Hematuria (macroscopic or detected via urine dipstick/microscopy). Ecchymoses (bruising). Petechiae. Epistaxis (nosebleeds). Gastrointestinal bleeding (melena, hematemesis, or positive fecal occult blood test).
- •Cerebral hemorrhage. Medical records available with sufficient clinical and laboratory data to assess eligibility and study variables.
- •Patients from two distinct periods:
- •Historical Control Group: Patients tested for Vitamin C "as needed" based on traditional medical judgment.
- •Active Group: Patients tested systematically according to Scurvy Suspicion upon Hemorrhagic Risk (SFI) criteria after protocol implementation.
排除标准
- 未提供
结局指标
主要结局
The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.
时间窗: The total study duration is expected to be around 4 months (3 months retrospective + 1 month prospective), but data collection may continue if necessary to reach the required sample size.
Definition of the Primary Outcome: Vitamin C deficiency will be determined based on serum ascorbic acid levels measured through blood sampling. A deficient status is defined as a serum ascorbic acid concentration below the reference values established by the central laboratory (Cerba, Paris, France). Only samples processed within 2 hours of collection will be considered valid due to the instability of ascorbic acid.
次要结局
未报告次要终点
研究者
Purcarea Adrian
MD, PhD
Internist.Ro
