Description of Fluid Balance in Patients With Acute Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT02523872|
Recruitment Status : Unknown
Verified August 2015 by Smiths Medical, ASD, Inc..
Recruitment status was: Enrolling by invitation
First Posted : August 14, 2015
Last Update Posted : August 14, 2015
|Condition or disease|
Disruption of fluid balance is common in critical illness. Many critical illnesses are inflammatory in nature and associated with capillary leak and swelling of tissues. While fluid administration may be necessary for the immediate resuscitation of a patient in shock, in the long term it may worsen survival and lead to complications. This is especially true in acute respiratory failure, where excess fluid can lead to a longer duration of mechanical ventilation, longer time in the ICU, and a greater need for dialysis. There is also evidence that conservative fluid administration can prevent complications. Fluid overload is associated with increased healthcare resource utilization and cost.
Much of the fluid administered to patients while in the adult ICU in the United States is administered as medications via large volume infusion pumps. This is a descriptive study to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration. The information will be used to design an interventional trial of small volume medication infusion.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Description of Fluid Balance in Patients With Acute Respiratory Failure|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Acute respiratory failure
Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration
- Mortality [ Time Frame: 28 Days ]Discharged from hospital alive or expired
- Ventilator-free days [ Time Frame: 28 Days ]Number of days of being alive and unassisted breathing by 28 days after time=0
- ICU-free days [ Time Frame: 28 Days ]Number of days alive and out of ICU-level care by 28 days after time=0
- Dialysis use [ Time Frame: 28 Days ]Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™)
- Sequential Organ Failure Assessment (SOFA) [ Time Frame: 28 Days ]Mean and highest scores after T=0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523872
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Carl Shanholtz, MD||University of Maryland, College Park|