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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
Sponsor:
Information provided by (Responsible Party):
Smiths Medical, ASD, Inc.

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.

Condition or disease
Respiratory Insufficiency

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Acute respiratory failure
Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration



Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 Days ]
    Discharged from hospital alive or expired

  2. Ventilator-free days [ Time Frame: 28 Days ]
    Number of days of being alive and unassisted breathing by 28 days after time=0

  3. ICU-free days [ Time Frame: 28 Days ]
    Number of days alive and out of ICU-level care by 28 days after time=0

  4. Dialysis use [ Time Frame: 28 Days ]
    Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™)

  5. Sequential Organ Failure Assessment (SOFA) [ Time Frame: 28 Days ]
    Mean and highest scores after T=0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Smiths Medical, ASD, Inc.
Investigators
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Principal Investigator: Carl Shanholtz, MD University of Maryland, College Park
Publications:

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Responsible Party: Smiths Medical, ASD, Inc.
ClinicalTrials.gov Identifier: NCT02523872    
Other Study ID Numbers: HP-00064591
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015
Keywords provided by Smiths Medical, ASD, Inc.:
Fluid overload
Acute respiratory failure
Acute respiratory distress syndrome
Medication administration
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases