NCT02523872

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

August 13, 2015

Last Update Submit

August 13, 2015

Conditions

Respiratory Insufficiency

Keywords

Fluid overloadAcute respiratory failureAcute respiratory distress syndromeMedication administration

Outcome Measures

Primary Outcomes (5)

  • Mortality

    Discharged from hospital alive or expired

    28 Days

  • Ventilator-free days

    Number of days of being alive and unassisted breathing by 28 days after time=0

    28 Days

  • ICU-free days

    Number of days alive and out of ICU-level care by 28 days after time=0

    28 Days

  • Dialysis use

    Use of intermittent hemodialysis, continuous renal replacement therapy (CvvH, CvvHD), ultrafiltration (intermittent or SCUF), or aquapheresis (Aquadex™)

    28 Days

  • Sequential Organ Failure Assessment (SOFA)

    Mean and highest scores after T=0

    28 Days

Study Arms (1)

Acute respiratory failure

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (8)

  • Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

    PMID: 11794169BACKGROUND

  • Alsous F, Khamiees M, DeGirolamo A, Amoateng-Adjepong Y, Manthous CA. Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest. 2000 Jun;117(6):1749-54. doi: 10.1378/chest.117.6.1749.

    PMID: 10858412BACKGROUND

  • Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26.

    PMID: 21615299BACKGROUND

  • National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

    PMID: 16714767BACKGROUND

  • Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.

    PMID: 14578723BACKGROUND

  • Li G, Malinchoc M, Cartin-Ceba R, Venkata CV, Kor DJ, Peters SG, Hubmayr RD, Gajic O. Eight-year trend of acute respiratory distress syndrome: a population-based study in Olmsted County, Minnesota. Am J Respir Crit Care Med. 2011 Jan 1;183(1):59-66. doi: 10.1164/rccm.201003-0436OC. Epub 2010 Aug 6.

    PMID: 20693377BACKGROUND

  • Child DL, Cao Z, Seiberlich LE, Brown H, Greenberg J, Swanson A, Sewall MR, Robinson SB. The costs of fluid overload in the adult intensive care unit: is a small-volume infusion model a proactive solution? Clinicoecon Outcomes Res. 2014 Dec 15;7:1-8. doi: 10.2147/CEOR.S72776. eCollection 2015.

    PMID: 25548524BACKGROUND

  • Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.

    PMID: 11594901BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyEdemaRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases

Study Officials

  • Carl Shanholtz, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

US(1)