The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Critically Ill Patients
Information source: Ziekenhuis Netwerk Antwerpen (ZNA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intra-Abdominal Hypertension
Intervention: furosemide (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ziekenhuis Netwerk Antwerpen (ZNA) Overall contact: Inneke E De laet, MD, Phone: +32476216120, Email: inneke.delaet@zna.be
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.
Clinical Details
Official title: The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Mechanically Ventilated Critically Ill Patients With Secondary Intra-abdominal Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: intra-abdominal pressure
Secondary outcome: serum creatinineneed for renal replacement therapy ICU mortality acid-base status hospital and 28d mortality duration of mechanical ventilation ICU length of stay vasopressor dose fluid balance SOFA score
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult (>18y)
- Sedation (Richmond Agitation and Sedation Score RASS ≤ -3) and mechanical ventilation
anticipated to last for at least an additional 72h
- Indication for IAP monitoring according to the recommendations published by the WSACS
- IAP ≥ 12mmHg (intravesical IAP measurement according to WSACS guidelines)
- Absence of surgically treatable abdominal lesions
- Presence of fluid overload
Exclusion Criteria:
- Pregnancy or lactation
- Assisted spontaneous breathing ventilator mode
- Chronic diuretic therapy or on diuretics during inclusion
- Contra-indication to bladder catheterization such as bladder surgery or genitourinary
trauma
- Known hypersensitivity to furosemide
- Renal failure Acute Kidney Injury Network (AKIN) class 3
- Patients requiring high dose vasopressors (norepinephrine >0. 5µg/kg/min, dobutamine
>10µg/kg/min or dopamine>10µg/kg/min, epinephrine>0. 5µg/kg/min)
- Intra-abdominal pressure (IAP) >25mmHg at study entry
- DNR orders in effect (other than DNR 1 'no CPR' order)
- Patient not expected to survive for 7 days
- Advanced liver cirrhosis (see pharmaceutical information on furosemide)
- paO2/FiO2 ratio of <100
- oliguria <500mL/24h preceding inclusion
Locations and Contacts
Inneke E De laet, MD, Phone: +32476216120, Email: inneke.delaet@zna.be
ZNA Stuivenberg Intensive Care Unit, Antwerpen 2060, Belgium; Recruiting Inneke E De laet, MD, Phone: +32476216120, Email: inneke.delaet@zna.be Manu Malbrain, MD PhD, Phone: +3232177399, Email: manu.malbrain@zna.be
Additional Information
World Society for the Abdominal Compartment Syndrome Official Website
Starting date: February 2010
Last updated: February 19, 2010
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