临床试验/NCT01784458

NCT01784458已完成不适用

Observational Study of Relationship Between Intra-abdominal Hypertension and Severe Sepsis in Surgical Patients

University of Ulsan0 个研究点目标入组 46 人开始时间: 2009年3月最近更新: 2013年2月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Ulsan
入组人数: 46
主要终点: effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal cavity
many studies have proved IAP as a prognostic factor that elevated IAP influences hemodynamics and multiple organs dysfunction
In previous studies, most of them was based on the septic patients of medical diseases. And it is rare about sepsis of surgical diseases such as traumatized or postoperative patients
We hypothesized that intra-abdominal hypertension may affect clinical course such as length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of enteral feeding and mortality
Our study was aimed to investigate prevalence of IAH and risk factors and to analyze clinical course and prognosis influenced by IAH in surgical patients with severe sepsis

详细描述

Inclusion criteria older than 18 diagnosed as severe sepsis agreed on informed consent
Exclusion criteria refused to participate in the study traumatic injuries on urethra or bladder open abdomen status
Definition of severe sepsis organ failure more than one organ with sepsis arterial blood lactate concentration of at least 4mmol/L hypotension with a systolic blood pressure lower than 90mmHg
Definition of intra-abdominal hypertension intra-abdominal pressure more than 12mmHg
Measurement of IAP measuring via three lument urinary catheter measuring after filling with 25ml normal saline measuring in supine position at level of mid-axillary line on iliac crest measuring three times a day during ICU stay

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•older than 18-year
•agreed on informed consent
•diagnosed with severe sepsis

排除标准

•traumatic injuries on urethra or bladder
•open abdomen status

结局指标

主要结局

effects of intra-abdominal hypertension on clinical course and outcome in surgical patients with severe sepsis

时间窗: within 60 days after admission in surgical intensive care unit

length of ICU stay length of hospital stay ventilator free days effect on enteral feeding 28 day and 60 day mortality

次要结局

未报告次要终点

研究者

发起方

University of Ulsan

申办方类型

Other

责任方

Principal Investigator

主要研究者

Kyu-Hyouck Kyoung

kyu-Hyouck Kyoung/clinical assistant professor

University of Ulsan

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