Red Cell Distribution Width as a Predictor of Liver Injury in Cardiac Surgery: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- To determine the association between preoperative red cell distribution width (RDW) levels
研究概览
简要总结
After the approval of the institutional Ethics committee, a Prospective observational study shall be conducted in patients belonging to inclusion criteria who shall be planned for cardiac surgery. Informed consent will be taken from all patients before the study by the investigator. Data Collection: 1.Preoperative Phase: Patient Demographics: Age, sex, weight, height, and BMI. Clinical History: Co-morbidities (e.g., diabetes, hypertension), baseline liver function, and medications. Laboratory Tests : Complete blood count (including RDW) . Liver function tests (AST, ALT, total bilirubin, albumin). Nutritional markers (iron, folate, vitamin 812) 2. lntraoperative Phase: Duration of cardiopulmonary bypass and aortic cross-c lamp. lntra operative blood loss and transfusion requirements . Use of vasopressors and hemodynamic data. 3.Postoperative Phase: Daily RDW Measurements: Collected for the first S postoperative days.Liver Function Tests (LFTs) : Repeated daily for 5 days or until discharge. Inflammatory Markers: C-reactive protein (CRP), interleukin-6 (IL-6).Outcomes : Incidence and severity of liver injury (defined as AST/ALT >2x upper limit of normal). Secondary outcomes, include renal dysfunction, sepsis, length of ICU and hospital stay, and all-cause mortality. Definitions 1.Liver Injury (LI) : Defined as an elevation of AST or ALT greater than 2 times the upper limit of normal (ULN) within the first S postoperative days . 2.Severe LI : Defined as AST/ALT >Sx ULN or in association with bilirubin >2x ULN. 3.Postoperative Complications: Acute kidney injury (AKI) based on KDIGO criteria. Prolonged mechanical ventilation (>24 hours). Sepsis as per Sepsis-3 definition.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18 years-80 years) scheduled for elective or emergency cardiac surgery with CPB, including coronary artery bypass grafting (CABG), valve replacements, or aortic aneurysm repair.
- •Availability of preoperative and postoperative laboratory data.
排除标准
- •1.Patients with preexisting severe liver disease (e.g., cirrhosis, chronic hepatitis).
- •2.Active hematological disorders or malignancy.
- •3.Recent blood transfusions (within 1 month before surgery).
- •4.Incomplete perioperative data or follow-up.
结局指标
主要结局
To determine the association between preoperative red cell distribution width (RDW) levels
时间窗: Preoperative period and everyday of postoperative period for 5 days or until discharge
and the incidence of liver injury in patients undergoing cardiac surgery with cardiopulmonary
时间窗: Preoperative period and everyday of postoperative period for 5 days or until discharge
bypass (CPB)
时间窗: Preoperative period and everyday of postoperative period for 5 days or until discharge
次要结局
- To assess postoperative changes in RDW levels and their correlation with the severity(of liver injury)
- To examine the relationship between RDW and systemic inflammation, oxidative stress, and nutritional deficiencies (e.g., iron, folate, and vitamin B12)(Everyday of postoperative period for 5 days or until discharge)
- To analyze the impact of intraoperative variables, such as cardiopulmonary bypass(duration, aortic cross-clamp time, and intraoperative blood loss, on RDW and liver)
- To investigate the prognostic value of RDW in predicting the following outcomes: all-cause in-hospital mortality, length of ICU and hospital stay, incidence of postoperative complications, including acute kidney injury,(sepsis, and prolonged mechanical ventilation)
- To explore the effect of preoperative blood transfusions on RDW levels and their(potential influence on postoperative liver injury and other complications)
- To determine the utility of RDW as a cost-effective biomarker for early risk(stratification and prognosis in cardiac surgery patients)
研究者
Dr Prasanta Kumar Das
All India Institute of Medical Sciences, Bhubaneswar