DRKS00006556招募中不适用
Prospective observational study to optimize and simplify the diagnosis of pathologically increased intra-abdominal pressure in critically ill children - pedACS concept study
Medizinische Hochschule Hannover0 个研究点目标入组 150 人开始时间: 2014年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 38 Pregnancy 至 18 Years(—)
- 性别
- All
入选标准
- •All term infants and pediatric patients between 0 and 18 years of life who are taken to the interdisciplinary pediatric intensive care unit of the Medical University of Hannover and who need anyway - due to their illness or treatment - an abdominal drainage (wound or ascites drainage, peritoneal dialysis catheter etc.) and a gastric tube and / or a urinary catheter might be included in this study. For this purpose, patients and parents are informed in detail about the nature, meaning and objectives of the study and must have expressly agreed to their participation and transmitted a written consent form before the start of measurements. Against the background of nasopharyngeal and esophagogastric proportions formerly preterms can not be included in the study before reaching the expected delivery date in cases of then newly emerging risk factors and new-onset intra-abdominal hypertension.
- •Preferably, IAP should be measured in children and adolescents at risk for the development of intra-abdominal hypertension (IAH). Related risk factors include all disease entities associated with a pathology and especially inflammation of the abdominal and retroperitoneal spaces or therein located organs and tissues (eg, peritonitis, perforation, pancreatitis, ileus, volvulus, necrotizing / infectious enterocolitis, hemorrhage, tumor / space-occupying processes). Abdominal wall closures (in cases of congenital abdominal wall or diaphragmatic hernia) and large-for-size organ transplants are considered prototypes of IAH-inducing diseases, since the intra-abdominal filling volume required for a tension-free abdominal closure is insufficient (especially in neonatal patients). Intra-parenchymal and cavitary fluid collections that are observed particularly in the context of capillary leak due to sepsis and systemic inflammation are the most common cause group for IAH and ACS in childhood [Beck 2001]. In addition, hypothermia, positive balance, (mass) transfusions, mechanical ventilation, hypotension and acidosis could be identified as general risk factors for the development of IAH and ACS [Holodinsky 2013, Malbrain 2013].
排除标准
- •Against the background of nasopharyngeal and esophagogastric size ratios preterm infants (Also excluded are all pediatric patients who have a disease entity of the nasopharynx and / or the upper gastrointestinal tract. These include in particular those children who need surgery or differentiated interventional as well as non-surgical therapies such as dilatation or radiation due to injury, disease or deformity in these areas or have already been operated or treated, respectively. In children and adolescents with a known, suspected or contemporaneous disturbance of the gastric muscle tone as well as following esophageal or gastric surgery (especially anastomosis in esophageal atresia, stomach pull-up, fundoplication or placement of percutaneous endoscopic gastrostomy) no reliable intra-gastric pressure measurement can be expected.
- •Children and young people with a known or suspected neurogenic bladder dysfunction can be included in the study; however, due to the imperfection of measured intra-vesical pressures bladder pressure measurements must be omitted. All other parameters can be determined, correlated and statistically analyzed.
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