Clinical Trial: The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Critically Ill Patients

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Mechanically Ventilated Critically Ill Patients With Secondary Intra-abdominal Hypertension

Brief Summary: Intra-abdominal hypertension (IAH) is a frequent cause of organ dysfunction in critically ill patients. Secondary IAH is mainly caused by excessive fluid resuscitation.The World Society for the Abdominal Compartment Syndrome (WSACS) recommends using diuretics to remove excess fluids and decrease intra-abdominal pressure (IAP). However, critically ill patients may not tolerate negative fluid balance in the acute phase of their disease and the injured kidney may not respond to diuretics. The aim of this study is to evaluate the influence of furosemide on fluid balance, IAP and kidney function in critically ill patients.

Detailed Summary:

Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have been shown to cause organ dysfunction and mortality in different populations of critically ill patients. According to consensus definitions published by the World Society for the Abdominal Compartment Syndrome (WSACS), secondary IAH is due to a disease process outside the abdominal cavity. It is mainly caused by massive fluid resuscitation leading to bowel and abdominal wall edema or increased intra-abdominal volume and decreased abdominal wall compliance. Large observational studies have shown that positive fluid balance is an independent risk factor for mortality. The development of secondary IAH may be one of the mechanisms involved in this phenomenon. This has lead to the hypothesis that prognosis may be improved by managing fluid overload and aiming for a negative fluid balance as soon as possible after the resuscitation phase of the disease.

Several authors have shown in case reports and small series that renal replacement therapy with ultrafiltration can be used successfully to remove excess fluid and lower intra-abdominal pressure (IAP), but renal replacement therapy is invasive and clinicians may be reluctant in considering this therapy in patients with preserved diuresis and kidney function. In an effort to achieve the same goal using a less invasive technique, the new medical management algorithm for IAH published by the WSACS recommends the use of judicious diuresis in order to achieve a negative fluid balance and a decrease in IAP.

However, the kidney is especially sensitive to the deleterious effects of IAH and may be unresponsive to diuretics in the presence of IAH. Also, ongoing inflammation and capillary leak may lead to relative hypovolemia and impaired response to diuretics.


Sponsor: Ziekenhuis Netwerk Antwerpen (ZNA)

Current Primary Outcome: intra-abdominal pressure [ Time Frame: every 4 hours during furosemide administration and daily for 7 days ]

Original Primary Outcome: intra-abdominal pressure [ Time Frame: 7 days ]

Current Secondary Outcome:

  • serum creatinine [ Time Frame: daily for 7 days ]
  • need for renal replacement therapy [ Time Frame: daily for 7 days ]
  • ICU mortality [ Time Frame: 3 months ]
  • acid-base status [ Time Frame: daily for 7 days ]
  • hospital and 28d mortality [ Time Frame: after 28 days and after 6 months ]
  • duration of mechanical ventilation [ Time Frame: 3 months ]
  • ICU length of stay [ Time Frame: 3 months ]
  • vasopressor dose [ Time Frame: daily for 7 days ]
  • fluid balance [ Time Frame: daily for 7 days ]
  • SOFA score [ Time Frame: daily for 7 days ]


Original Secondary Outcome:

  • SOFA score [ Time Frame: daily during 7d ]
  • serum creatinine [ Time Frame: daily during 7d ]
  • need for renal replacement therapy [ Time Frame: daily during 7d ]
  • ICU mortality [ Time Frame: at ICU discharge ]
  • acid-base status [ Time Frame: daily during 7d ]
  • hospital and 28d mortality [ Time Frame: after 28d and at hospital discharge ]
  • duration of mechanical ventilation [ Time Frame: at ICU discharge ]
  • ICU length of stay [ Time Frame: at ICU discharge ]
  • vasopressor dose [ Time Frame: daily during 7d ]
  • fluid balance [ Time Frame: daily for 7d ]


Information By: Ziekenhuis Netwerk Antwerpen (ZNA)

Dates:
Date Received: February 18, 2010
Date Started: February 2010
Date Completion: March 2012
Last Updated: February 19, 2010
Last Verified: February 2010