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

NCT01911702 | Completed Phase 2 DMC

• 1 other identifier: AOModena
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Abdomen

Outcome Measures

Primary Outcomes (1)

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

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

  within the first 30 days after surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

In this group patients receive volemic standard treatment (conventional)

Other: Standard fluidic resuscitation.

Restrictive Group

ACTIVE COMPARATOR

In this group patients receive volemic small treatment (restrictive)

Other: Volemic small treatment

Interventions

Standard fluidic resuscitation. OTHER

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.

Conventional Group

Volemic small treatment OTHER

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

Restrictive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Related Publications (8)

• Streat SJ, Plank LD, Hill GL. Overview of modern management of patients with critical injury and severe sepsis. World J Surg. 2000 Jun;24(6):655-63. doi: 10.1007/s002689910107.

  PMID: 10773117 BACKGROUND

• Raymond DP, Pelletier SJ, Crabtree TD, Schulman AM, Pruett TL, Sawyer RG. Surgical infection and the aging population. Am Surg. 2001 Sep;67(9):827-32; discussion 832-3.

  PMID: 11565758 BACKGROUND

• Farinas-Alvarez C, Farinas MC, Fernandez-Mazarrasa C, Llorca J, Casanova D, Delgado-Rodriguez M. Analysis of risk factors for nosocomial sepsis in surgical patients. Br J Surg. 2000 Aug;87(8):1076-81. doi: 10.1046/j.1365-2168.2000.01466.x.

  PMID: 10931054 BACKGROUND

• Stafford RE, Weigelt JA. Surgical infections in the critically ill. Curr Opin Crit Care. 2002 Oct;8(5):449-52. doi: 10.1097/00075198-200210000-00013.

  PMID: 12357114 BACKGROUND

• Madigan MC, Kemp CD, Johnson JC, Cotton BA. Secondary abdominal compartment syndrome after severe extremity injury: are early, aggressive fluid resuscitation strategies to blame? J Trauma. 2008 Feb;64(2):280-5. doi: 10.1097/TA.0b013e3181622bb6.

  PMID: 18301187 BACKGROUND

• Cotton BA, Guy JS, Morris JA Jr, Abumrad NN. The cellular, metabolic, and systemic consequences of aggressive fluid resuscitation strategies. Shock. 2006 Aug;26(2):115-21. doi: 10.1097/01.shk.0000209564.84822.f2.

  PMID: 16878017 BACKGROUND

• Marshall JC, Innes M. Intensive care unit management of intra-abdominal infection. Crit Care Med. 2003 Aug;31(8):2228-37. doi: 10.1097/01.CCM.0000087326.59341.51.

  PMID: 12973184 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000298158.12101.41.

  PMID: 18158437 BACKGROUND

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Massimo Girardis, Professor

  Azienda Ospedalier Universitaria di Modena

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07