Status and phase
Conditions
Treatments
About
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.
Full description
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:
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 terms of surgical complications, occurrence of organ failure, duration of mechanical ventilation and length of stay in ICU. Please refer to Section 6 for the definition of the endpoints / response variables for the secondary goals.
PLAN STUDY Study setting
The study will be conducted at the following facilities:
In the definition of acute abdomen, the following frameworks will be included:
primary peritonitis: bacterial contamination of the peritoneal cavity by microorganisms starting from extra-peritoneal sites (hematogenous in sepsis / bacteremia, from the female genital tract in the course of pelvic inflammatory disease (PID), from the retroperitoneum); translocation of microorganisms through the bowel
secondary peritonitis: bacterial contamination of the peritoneal cavity as a result of phlogosis or perforation of the digestive tract or female genital tract:
tertiary or relapsing peritonitis, understood as persistent or recurrent peritonitis after apparently adequate medical and surgical treatment of secondary peritonitis
intestinal ischemia
pancreatitis with or without evidence of hemorrhagic- necrotic areas
The condition of hypoperfusion is identified by:
Exclusion Criteria
In the definition of ACS, chest pain of suspected coronary origin with or without ST-segment elevation are included. According to the classification accepted by the European Society of Cardiology (ESC) and by the American College of Cardiology (ACC), the serum dosage of cardiac troponins can make the diagnosis of myocardial infarction.
STUDY PROCEDURES Screening and inclusion
At the entrance to the ICU all patients that meet the criteria for inclusion and don't present exclusion criteria - will be evaluated for randomization.
The attending physician will have to notify the coordinating center as soon deemed to have identified a patient to be enrolled. The coordinating center is at the Intensive Care Unit of the University Hospital of Modena.
Randomization must be done at the time of admission to ICU.
The method of randomization will be by "parallel group", the type of simple randomization and the randomization list will be obtained through the use of a random number generator computerized in a 1:1 ratio. Patients who meet the inclusion criteria are assigned over the telephone by medical coordinator:
Group "conventional"
Goals of the treatment:
To achieve the therapeutic goals set out above will be executed a volemic fill until reaching central venous pressure values of 8-10 mmHg. Crystalloid solutions and specifically balanced III, Ringer solutions or alternatively glucose solution will be infused at 5% in patients with serum sodium ≥ 145 milliequivalent (mEq) / L.
For this group of patients, the overall water balance won't be binding. If after proper filling the targets aren't yet achieved, the patient will begin infusion of vasoactive drugs following the practice of department.
If you are unable to get a goal value of venous saturation you can consider:
Group "restrictive"
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 in order to bring the budget of the patient to 10-15 ml / kg in 24 hours.
DATA COLLECTION Data Collection Program
Data collection will be done by compiling data collection forms. In particular, the following types of data collection formats will be filled:
The basal card will contain:
The final board will collect data until it will be verified:
END POINT / VARIABLE RESPONSE
Study end point:
Primary: Mortality at 30 days
Secondary:
In the definition of surgical complications all the following situations are included:
The accepted definition of abdominal hypertension is hypertension of the abdominal cavity of retroperitoneal, intraperitoneal or parietal origin. The measurement system accepted in the study is exclusively that one of the intravesical bladder catheterization. The values considered as reference are:
SIZE OF THE STUDY AND DATA ANALYSIS CRITERIA This is a phase II study, which is exploratory and estimative and that involves randomization of all recruitable patients during the period of study all over the three centers involved in the work. The study will begin on January 2010 and will last for 3 years. The sample size has been calculated on the basis of the available data at the Post-Operative Intensive Care Unit of the Hospital in 2007: these data showed a mortality of the patients with acute abdomen undergoing abdominal surgery under emergency and presenting at the moment of arrival to Post Operative Intensive Therapy at least a sign of hypoperfusion of 30%. Assuming a two-tailed alpha level <0.05 and a power of 80%, we have calculated that 100 patients per arm are needed to detect an absolute reduction in mortality of 15%. This reduction appears to be significant from the clinical point of view considering previous trials of fluidic therapy in shocked patients . For comparisons between the means, the t-student test will be used. For comparison of events frequencies the χ2 test or Fisher's test - as indicated - will be used. A p <0.05 will be considered statistically significant. Static analysis will be performed using version 16.0 of SPSS software.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
99 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal