Description of Fluid Balance in Patients With Acute Respiratory Failure

August 13, 2015 updated by: Smiths Medical, ASD, Inc.
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 Days
Discharged from hospital alive or expired
28 Days
Ventilator-free days
Time Frame: 28 Days
Number of days of being alive and unassisted breathing by 28 days after time=0
28 Days
ICU-free days
Time Frame: 28 Days
Number of days alive and out of ICU-level care by 28 days after time=0
28 Days
Dialysis use
Time Frame: 28 Days
Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™)
28 Days
Sequential Organ Failure Assessment (SOFA)
Time Frame: 28 Days
Mean and highest scores after T=0
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smiths Medical, ASD, Inc.

Investigators

  • Principal Investigator: Carl Shanholtz, MD, University of Maryland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00064591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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