Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01911702|
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Abdomen||Other: Standard fluidic resuscitation. Other: Volemic small treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MANAGEMENT OF THE PATIENT WITH ACUTE ABDOMEN SUBMITTED TO URGENT ABDOMINAL SURGERY: a Pilot Randomized Multicentre Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: Conventional Group
In this group patients receive volemic standard treatment (conventional)
Other: Standard fluidic resuscitation.
Active Comparator: Restrictive Group
In this group patients receive volemic small treatment (restrictive)
Other: Volemic small treatment
Goals of the treatment:
To achieve the therapeutic goals set out above will be executed a volemic fill up to values of PVC ≤ 5 mmHg or at maximum values of 2 mmHg more the incoming If after proper filling the targets aren't yet achieved, the patient will begin infusion of vasoactive drugs following the practice of department. If after 12 hours of admission the water balance will be > 10-15 ml / kg / h an infusion of furosemide should be initiated
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911702
|Study Chair:||Massimo Girardis, Professor||Azienda Ospedalier Universitaria di Modena|