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

NCT01911702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-07-30

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Principal Investigators

  • Massimo Girardis, Professor · Azienda Ospedalier Universitaria di Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01911702 on ClinicalTrials.gov