MANAGEMENT OF THE PATIENT WITH ACUTE ABDOMEN SUBMITTED TO URGENT ABDOMINAL SURGERY: a Pilot Randomized Multicentre Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- differences between the two treatment groups with different fluidic strategy in terms of 30-day mortality.
研究概览
简要总结
Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to intra-abdominal generalized infection. With the exception of the primary ones which are the result of a bacterial translocation from the gastro-intestinal tract or an abdominal contamination for hematogenous way sometimes treatable with medical therapy alone, peritonitis represents a complex condition that requires an early surgical treatment.
Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when associated with a systemic framework of severe sepsis. This variability is linked to a number of risk factors, including advanced age of the patients, the presence of comorbidity, male sex, a poor nutritional status, and a number of re-operations; as well as specific characteristics related to the type of infection, the timing of surgery, the beginning of an appropriate and early antibiotic therapy.The post-operative treatment of the patient with peritonitis significantly affects the outcome of the same. The presence of peritonitis and then the seizure of large volumes of liquids and the possible state of systemic vasodilation induced by the infectious process, provide a framework of hypovolemia. There is a literature that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.
详细描述
DEPARTMENT OF GENERAL SURGERY AND SURGICAL SPECIALITIES SERVICE OF ANESTHESIOLOGY AND REANIMATION INTENSIVE CARE UNIT
Head: Prof. M. Girardis
MANAGEMENT OF THE PATIENT WITH ACUTE ABDOMEN SUBMITTED TO URGENT ABDOMINAL SURGERY: pilot study randomized multicentre
INTRODUCTION Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to intra-abdominal generalized infection. Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when associated with a systemic framework of severe sepsis. This variability is linked to a number of risk factors, including advanced age of the patients, the presence of comorbidity, male sex, a poor nutritional status, and a number of reoperations; as well as specific characteristics related to the type of infection, the timing of surgery, the beginning of an appropriate and early antibiotic therapy.
The post-operative treatment of the patient with peritonitis significantly affects the outcome of the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion.
排除标准
- •Patients with chronic renal failure already receiving dialysis treatment
- •Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3
- •Patients judged at the admission not subject to resuscitative measures for severity and comorbidity
- •Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC)
- •Patients scheduled for Orthotopic Liver Transplantation (OLT)
- •Patients younger than 18 years old
结局指标
主要结局
differences between the two treatment groups with different fluidic strategy in terms of 30-day mortality.
时间窗: within the first 30 days after surgery
The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.
次要结局
- differences between the two treatment groups with different fluidic strategy in terms of surgical complications(within the forst 30 days after surgery)
- differences between the two treatment groups with different fluidic strategy in terms of occurrence of organ failure,(within the first 30 days after surgery)
- differences between the two treatment groups with different fluidic strategy in terms of duration of mechanical ventilation(within the first 30 days after surgery)
- differences between the two treatment groups with different fluidic strategy in terms of length of stay in ICU(within 6 months after surgery)
研究者
Emanuela Biagioni
DR
Azienda Ospedaliero-Universitaria di Modena
