The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Critically Ill Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 22, 2010
February 1, 2010
1.8 years
February 18, 2010
February 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra-abdominal pressure
every 4 hours during furosemide administration and daily for 7 days
Secondary Outcomes (10)
serum creatinine
daily for 7 days
need for renal replacement therapy
daily for 7 days
ICU mortality
3 months
acid-base status
daily for 7 days
hospital and 28d mortality
after 28 days and after 6 months
- +5 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONPatients will be receiving standard of care ICU treatment of their underlying disease according to internationally accepted guidelines and recommendations.
Furosemide group
EXPERIMENTALpatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or lactation
- Assisted spontaneous breathing ventilator mode
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ZNA Stuivenberg Intensive Care Unit
Antwerp, 2060, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 19, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
February 22, 2010
Record last verified: 2010-02