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临床试验/CTRI/2025/04/085322
CTRI/2025/04/085322尚未招募不适用

Serum D-dimer and procalcitonin levels atadmission as predictors of severity in acute pancreatitis: an observationalstudy

All India Institute of Medical Sciences Kalyani1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
1.To determine if serum D-dimer and procalcitonin levels at the time of admission can predict the severity of acute pancreatitis.

研究概览

简要总结

This prospective observational cohort study aims to assessthe predictive value of serum D-dimer and procalcitonin levels at admission indetermining the severity of acute pancreatitis (AP). The study will includeadult patients (18–70 years) presenting within 24 hours of symptom onset. TheRevised Atlanta Classification and Modified Marshall Scoring System will beused to classify AP severity and assess organ dysfunction. Given the associationsof AP with systemic inflammation, sepsis, and microvascular thrombosis,procalcitonin and D-dimer levels may serve as early biomarkers for severityassessment. A total of 62 patients will be recruited, accounting for a 10%dropout rate. Blood samples will be collected at admission for D-dimer andprocalcitonin measurements. Patients will be monitored for up to 8 days oruntil discharge for development of complications, organ failure, and outcomes.Data will be analysed using SPSS, with ROC curve analysis to evaluate thepredictive accuracy of both biomarkers. Multiple regression will identifyindependent predictors of severity and mortality. The study seeks to establishwhether these biomarkers can aid in early risk stratification and guideclinical decision-making in acute pancreatitis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult patients (18-70 years) with acute pancreatitis presenting within 24 hrs of symptom onset.

排除标准

  • 1.Pregnancy.
  • 2.Patients presenting more than 24 hours of symptom onset.
  • 3.Chronic pancreatitis 4.Recurrent pancreatitis 5.Age less than 18 years old or over 70 years old 6.Anticoagulant drug use 7.Cancer 8.Thrombotic diseases 9.Liver cirrhosis 10.Patient on immunosuppressive therapy 11.Refusal to give consent.

结局指标

主要结局

1.To determine if serum D-dimer and procalcitonin levels at the time of admission can predict the severity of acute pancreatitis.

时间窗: Preparation and ethical approval-1-2 months | Data collection- 3 months | Data analysis, reporting and dissemination:1 month

次要结局

  • 2.To evaluate whether D-dimer and procalcitonin levels are associated with the development of complications and mortality in patients with acute pancreatitis.(3.To determine the most reliable predictor between D-dimer and procalcitonin for early risk assessment in Acute Pancreatitis patients.)

研究者

发起方
All India Institute of Medical Sciences Kalyani
申办方类型
Research institution

研究点 (1)

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