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

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ClinicalTrials.gov Identifier: NCT01911702
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Emanuela Biagioni, Azienda Ospedaliero-Universitaria di Modena

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.


Condition or disease Intervention/treatment Phase
Acute Abdomen Other: Standard fluidic resuscitation. Other: Volemic small treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Conventional Group
In this group patients receive volemic standard treatment (conventional)
Other: Standard fluidic resuscitation.

Goals:

  1. arterial pressure mean ≥ 65 mmHg or equal to the pre-operative
  2. diuretic rhythm ≥ 1 ml / Kg / h
  3. venous saturation in vena cava ≥ 70% or mixed venous saturation as Swan Ganz's catheter (SG) ≥ 65%
  4. BE> - 3
  5. Central Venous Pression (PVC) ≥ 8 mmHg; for patients undergoing mechanical ventilation, this limit may be raised to 12-15 mmHg.

Active Comparator: Restrictive Group
In this group patients receive volemic small treatment (restrictive)
Other: Volemic small treatment

Goals of the treatment:

  1. arterial pressure mean ≥ 60 mmHg or ≥ 10% less than the preoperative values
  2. diuretic rhythm ≥ 0.5 ml / kg / h
  3. venous saturation in vena cava ≥ 60% or mixed venous saturation ≥ 55% by SG
  4. BE> - 5
  5. PVC goal not necessary

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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. differences between the two treatment groups with different fluidic strategy in terms of surgical complications [ Time Frame: within the forst 30 days after surgery ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Patients with chronic renal failure already receiving dialysis treatment
  2. Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3
  3. Patients judged at the admission not subject to resuscitative measures for severity and comorbidity
  4. 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)
  5. Patients scheduled for Orthotopic Liver Transplantation (OLT)
  6. Patients younger than 18 years old

Information from the National Library of Medicine

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


Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
Investigators
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Study Chair: Massimo Girardis, Professor Azienda Ospedalier Universitaria di Modena
Publications:
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

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Responsible Party: Emanuela Biagioni, DR, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT01911702    
Other Study ID Numbers: AOModena
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Abdomen, Acute
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive