An interventional study of furosemide in Intra-Abdominal Hypertension, sponsored by Ziekenhuis Netwerk Antwerpen (ZNA). Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-22.
Sponsored by Ziekenhuis Netwerk Antwerpen (ZNA) · Not applicable, Interventional, and Treatment
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.
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.
We plan a multicenter study to evaluate the influence of furosemide on fluid balance and IAP in critically ill patients with secondary intra-abdominal hypertension and to document the effect on the function of other organ systems. The aim of this study is to evaluate the feasibility and the safety of the furosemide administration protocol and to provide preliminary data to allow for an adequate power calculation.
61 studies on the registry are indexed under Intra-Abdominal Hypertension; 12 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 29 interventional studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →Ziekenhuis Netwerk Antwerpen (ZNA) is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients will be receiving standard of care ICU treatment of their underlying disease according to internationally accepted guidelines and recommendations.
patients will be receiving standard of care ICU treatment of their underlying condition according to international guidelines and recommendations. In addition, furosemide will be administered in continuous infusion as per protocol in order to achieve a preset target diuresis that is adjusted according to haemodynamic tolerance.
Drug: furosemide
Loading dose: 0,5mg/kg Start continuous infusion at a dose of 0,1mg/kg/h and titrate according to diuretic response. Target value for diuresis = (amount of fluids administered at inclusion/kg/h) + 0.5mL/kg/h If safety check is satisfactory: increase target diuresis with 1mL/kg/h per 4h to a maximum of (amount of fluids administered at inclusion/kg/h) + 2.5mL/kg/h Maximal dose of furosemide: 0.3mg/kg/h Safety check every 4h. Furosemide is administered for 24h. If safety checks are satisfactory, additional periods of 24 can be added up to a maximum of 72h.
Also known as: Lasix (Sanofi-Aventis)
intra-abdominal pressure
Time frame: every 4 hours during furosemide administration and daily for 7 days
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
This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Netwerk Antwerpen (ZNA)