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Description of Fluid Balance in Patients With Acute Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date August 13, 2015
First Posted Date August 14, 2015
Last Update Posted Date August 14, 2015
Study Start Date August 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2015)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Description of Fluid Balance in Patients With Acute Respiratory Failure
Official Title Description of Fluid Balance in Patients With Acute Respiratory Failure
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration
Condition Respiratory Insufficiency
Intervention Not Provided
Study Groups/Cohorts Acute respiratory failure
Patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 13, 2015)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02523872
Other Study ID Numbers HP-00064591
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Smiths Medical, ASD, Inc.
Study Sponsor Smiths Medical, ASD, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Carl Shanholtz, MD University of Maryland, College Park
PRS Account Smiths Medical, ASD, Inc.
Verification Date August 2015