Respiratory Insufficiency
Conditions
Keywords
Fluid overload, Acute respiratory failure, Acute respiratory distress syndrome, Medication 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.
Interventions
None listed
Sponsors
Smiths Medical, ASD, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 Days | Discharged from hospital alive or expired |
| Ventilator-free days | 28 Days | Number of days of being alive and unassisted breathing by 28 days after time=0 |
| ICU-free days | 28 Days | Number of days alive and out of ICU-level care by 28 days after time=0 |
| Dialysis use | 28 Days | Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™) |
| Sequential Organ Failure Assessment (SOFA) | 28 Days | Mean and highest scores after T=0 |
Countries
United States
Outcome results
None listed