Clinical Trial: Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: MANAGEMENT OF THE PATIENT WITH ACUTE ABDOMEN SUBMITTED TO URGENT ABDOMINAL SURGERY: a Pilot Randomized Multicentre Study

Brief Summary:

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.


Detailed Summary:

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.

The centers involved in the study will be three:

  1. post operative intensive care unit (ICU) - Modena University Hospital
  2. reanimation unit - Carpi Hospital
  3. intensive care unit (ICU) - Modena New Civil Hospital

OBJECTIVES PRIMARY OBJECTIVES: differences between the two treatment groups with different fluidic strategy in terms of 30-day mortality.

SECONDARY OBJECTIVES: differences between the two treatment groups with different fluidic strategy in
Sponsor: Azienda Ospedaliera - Universitaria di Modena

Current Primary Outcome: differences between the two treatment groups with different fluidic strategy in terms of 30-day mortality. [ Time Frame: within the first 30 days after surgery ]

The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • differences between the two treatment groups with different fluidic strategy in terms of surgical complications [ Time Frame: within the forst 30 days after surgery ]
  • differences between the two treatment groups with different fluidic strategy in terms of occurrence of organ failure, [ Time Frame: within the first 30 days after surgery ]
  • differences between the two treatment groups with different fluidic strategy in terms of duration of mechanical ventilation [ Time Frame: 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 [ Time Frame: within 6 months after surgery ]


Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliera - Universitaria di Modena

Dates:
Date Received: July 26, 2013
Date Started: January 2010
Date Completion:
Last Updated: July 26, 2013
Last Verified: July 2013