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临床试验/CTRI/2020/09/028076
CTRI/2020/09/028076招募中不适用

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

Sir ganga ram hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with severe acute pancreatitis in the age group of 18-65 years Patients with severe acute pancreatitis 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 tumour 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: admission till 30 days

次要结局

  • SOFA score(APACHE II scores)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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