Clinical trial NCT02523872: Description of Fluid Balance in Patients With Acute Respiratory Failure
Official title: Description of Fluid Balance in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Keywords: Fluid overload
Acute respiratory failure
Acute respiratory distress syndrome
Medication administration
Lead sponsor: Smiths Medical, ASD, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration

Brief summary: The specific aim of this study is 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Intubation and mechanical ventilation for ≤ 7 days
* An underlying condition associated with acute respiratory failure (e.g. pneumonia, ARDS, sepsis, asthma, COPD exacerbation)
* If in shock (MAP \< 60, fluid bolus ≥30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine ≤ 5 mcg/kg/min or low-dose (≤ 0.04 IU/min) vasopressin) there should be no fluid bolus (1000 mL crystalloid or equivalent) for at least 12 hours

Exclusion Criteria:

* Intubation or mechanical ventilation for \> 7 days
* Respiratory failure (requirement for positive pressure ventilation) in past 30 days
* Shock (MAP \< 60, fluid bolus ≥30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine ≤ 5 mcg/kg/min or low-dose vasopressin) requiring fluid bolus (1000 mL crystalloid or equivalent) within past 12 hours
* Presence of a condition making it unlikely that the patient will be liberated from mechanical ventilation within the next 28 days (e.g. quadriplegia, end-stage lung disease, massive stroke, etc.)
* Prognosis from underlying condition ≤ 28 days (estimated 28 day mortality from underlying condition \>50%)
* Likely intention (\>50% probability) to withhold or withdraw life-supportive care within next 28 days

Primary outcomes:
measure: Mortality
timeFrame: 28 Days
measure: Ventilator-free days
timeFrame: 28 Days
measure: ICU-free days
timeFrame: 28 Days
measure: Dialysis use
timeFrame: 28 Days
measure: Sequential Organ Failure Assessment (SOFA)
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Carl Shanholtz, MD
role: PRINCIPAL_INVESTIGATOR
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