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临床试验/NCT04525027
NCT04525027已完成不适用

Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis: A Prospective Observational Study

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2019年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
360
试验地点
1
主要终点
Mortality

研究概览

简要总结

Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. Abdominal Compartment Syndrome (ACS) is defined as IAP greater than 20 mm of Hg and is considered an abdominal catastrophe. Intra-abdominal Hypertension (IAH, Intra-abdominal pressure > 12mm of Hg), may contribute to early organ dysfunction, ACS and eventually hemodynamic collapse if left untreated. This signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop IAH /ACS and predicting mortality associated with the condition. Measurement of IAP will be done indirectly by measuring intravesicular pressure using modified kron's method. IAP will be measured at the time of admission into Intensive Care Unit (ICU) and every day thereafter during the initial five days of ICU admission. Any reading of IAP ≥12 mm of Hg shall be considered as IAH. SOFA and APACHE II score will be noted on the day of admission in the ICU. Any interventions, surgical or non surgical as per clinician's decision will be recorded. The patients will be followed up until discharge or mortality until 30 days. The proposed study aims to assess the predictive ability of IAP during the first 5 days of ICU admission for predicting mortality in patients with SAP. Prediction accuracy will also be compared with SOFA and APACHE II scores.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >Patients with severe acute pancreatitis in the age group of 18-65 years admitted to ICU within 72 hours of onset of symptoms

排除标准

  • Previous history of any abdominal or pelvic surgery
  • Known case of bladder tumor or bladder abnormality.
  • Difficulty in urinary catheterization
  • Use of neuromuscular blockade
  • Pregnant patients

结局指标

主要结局

Mortality

时间窗: 30 days from inclusion date

次要结局

未报告次要终点

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

VAMSIDHAR

Trainee

Sir Ganga Ram Hospital

研究点 (1)

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