NCT00310401

Brief Summary

The purpose of this study is to test the effectiveness of albuterol versus placebo with the following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce pulmonary edema, improve donor oxygenation, and increase the number of lungs available for transplantation, b) Developing a blood test to predict the development of primary graft dysfunction in lung transplant recipients, and c) treating brain dead organ donors with albuterol will decrease markers of primary graft dysfunction and lead to improved lung transplant recipient outcomes and to higher rates of lungs suitable for transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
506

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2006

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 2, 2013

Completed
Last Updated

March 16, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

March 1, 2006

Results QC Date

June 24, 2013

Last Update Submit

February 14, 2018

Conditions

Brain DeathOrgan DonorPulmonary Edema

Keywords

brain deathorgan donorpulmonary edemaalbuterolhypoxialung transplantationinfiltrates

Outcome Measures

Primary Outcomes (1)

  • Donor Oxygenation

    The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement

    Change from enrollment to organ procurement (about ~40h after enrollment)

Secondary Outcomes (4)

  • Number of Donor Lungs Used for Transplantation

    72 hours

  • Lung Compliance

    baseline and at organ procurement (about ~40h after enrollment)

  • Pulmonary Vascular Resistance

    72 hours

  • Chest X-ray Findings

    change from enrollment to organ procurement (about ~40h after enrollment)

Study Arms (2)

Albuterol

EXPERIMENTAL

Albuterol sulfate 5 mg dissolved in normal saline administered every 4 hours by nebulization

Drug: Albuterol

Saline

PLACEBO COMPARATOR

Saline administered every 4 hours by nebulization

Drug: AlbuterolDrug: Saline

Interventions

AlbuterolDRUG

5 mg nebulized q4h

Also known as: salbutamol
AlbuterolSaline
SalineDRUG

1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours

Also known as: placebo
Saline

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Brain death
  • Consent for lung donation and donor research
  • Release from coroner or medical examiner

You may not qualify if:

  • Age less than 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Transplant Donor Network

Oakland, California, 94612, United States

Location

Related Publications (24)

  • Ojo AO, Heinrichs D, Emond JC, McGowan JJ, Guidinger MK, Delmonico FL, Metzger RA. Organ donation and utilization in the USA. Am J Transplant. 2004;4 Suppl 9:27-37. doi: 10.1111/j.1600-6135.2004.00396.x.

    PMID: 15113353BACKGROUND

  • Rogers FB, Shackford SR, Trevisani GT, Davis JW, Mackersie RC, Hoyt DB. Neurogenic pulmonary edema in fatal and nonfatal head injuries. J Trauma. 1995 Nov;39(5):860-6; discussion 866-8. doi: 10.1097/00005373-199511000-00009.

    PMID: 7474001BACKGROUND

  • Simon RP. Neurogenic pulmonary edema. Neurol Clin. 1993 May;11(2):309-23.

    PMID: 8316188BACKGROUND

  • Matthay MA, Folkesson HG, Clerici C. Lung epithelial fluid transport and the resolution of pulmonary edema. Physiol Rev. 2002 Jul;82(3):569-600. doi: 10.1152/physrev.00003.2002.

    PMID: 12087129BACKGROUND

  • Ware LB, Fang X, Wang Y, Sakuma T, Hall TS, Matthay MA. Selected contribution: mechanisms that may stimulate the resolution of alveolar edema in the transplanted human lung. J Appl Physiol (1985). 2002 Nov;93(5):1869-74. doi: 10.1152/japplphysiol.00252.2002.

    PMID: 12381777BACKGROUND

  • Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.

    PMID: 12241936BACKGROUND

  • Bhorade SM, Vigneswaran W, McCabe MA, Garrity ER. Liberalization of donor criteria may expand the donor pool without adverse consequence in lung transplantation. J Heart Lung Transplant. 2000 Dec;19(12):1199-204. doi: 10.1016/s1053-2498(00)00215-1.

    PMID: 11124490BACKGROUND

  • Sundaresan S, Semenkovich J, Ochoa L, Richardson G, Trulock EP, Cooper JD, Patterson GA. Successful outcome of lung transplantation is not compromised by the use of marginal donor lungs. J Thorac Cardiovasc Surg. 1995 Jun;109(6):1075-9; discussion 1079-80. doi: 10.1016/S0022-5223(95)70190-7.

    PMID: 7776671BACKGROUND

  • Whiting D, Banerji A, Ross D, Levine M, Shpiner R, Lackey S, Ardehali A. Liberalization of donor criteria in lung transplantation. Am Surg. 2003 Oct;69(10):909-12.

    PMID: 14570373BACKGROUND

  • Verghese GM, Ware LB, Matthay BA, Matthay MA. Alveolar epithelial fluid transport and the resolution of clinically severe hydrostatic pulmonary edema. J Appl Physiol (1985). 1999 Oct;87(4):1301-12. doi: 10.1152/jappl.1999.87.4.1301.

    PMID: 10517756BACKGROUND

  • Ware LB, Matthay MA. Alveolar fluid clearance is impaired in the majority of patients with acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1376-83. doi: 10.1164/ajrccm.163.6.2004035.

    PMID: 11371404BACKGROUND

  • Matthay MA, Wiener-Kronish JP. Intact epithelial barrier function is critical for the resolution of alveolar edema in humans. Am Rev Respir Dis. 1990 Dec;142(6 Pt 1):1250-7. doi: 10.1164/ajrccm/142.6_Pt_1.1250.

    PMID: 2252240BACKGROUND

  • Ware LB, Golden JA, Finkbeiner WE, Matthay MA. Alveolar epithelial fluid transport capacity in reperfusion lung injury after lung transplantation. Am J Respir Crit Care Med. 1999 Mar;159(3):980-8. doi: 10.1164/ajrccm.159.3.9802105.

    PMID: 10051282BACKGROUND

  • Campbell AR, Folkesson HG, Berthiaume Y, Gutkowska J, Suzuki S, Matthay MA. Alveolar epithelial fluid clearance persists in the presence of moderate left atrial hypertension in sheep. J Appl Physiol (1985). 1999 Jan;86(1):139-51. doi: 10.1152/jappl.1999.86.1.139.

    PMID: 9887124BACKGROUND

  • Sakuma T, Okaniwa G, Nakada T, Nishimura T, Fujimura S, Matthay MA. Alveolar fluid clearance in the resected human lung. Am J Respir Crit Care Med. 1994 Aug;150(2):305-10. doi: 10.1164/ajrccm.150.2.8049807.

    PMID: 8049807BACKGROUND

  • Sartori C, Allemann Y, Duplain H, Lepori M, Egli M, Lipp E, Hutter D, Turini P, Hugli O, Cook S, Nicod P, Scherrer U. Salmeterol for the prevention of high-altitude pulmonary edema. N Engl J Med. 2002 May 23;346(21):1631-6. doi: 10.1056/NEJMoa013183.

    PMID: 12023995BACKGROUND

  • Perkins GD, McAuley DF, Thickett DR, Gao F. The beta-agonist lung injury trial (BALTI): a randomized placebo-controlled clinical trial. Am J Respir Crit Care Med. 2006 Feb 1;173(3):281-7. doi: 10.1164/rccm.200508-1302OC. Epub 2005 Oct 27.

    PMID: 16254268BACKGROUND

  • Atabai K, Ware LB, Snider ME, Koch P, Daniel B, Nuckton TJ, Matthay MA. Aerosolized beta(2)-adrenergic agonists achieve therapeutic levels in the pulmonary edema fluid of ventilated patients with acute respiratory failure. Intensive Care Med. 2002 Jun;28(6):705-11. doi: 10.1007/s00134-002-1282-x. Epub 2002 May 17.

    PMID: 12107675BACKGROUND

  • de Perrot M, Liu M, Waddell TK, Keshavjee S. Ischemia-reperfusion-induced lung injury. Am J Respir Crit Care Med. 2003 Feb 15;167(4):490-511. doi: 10.1164/rccm.200207-670SO.

    PMID: 12588712BACKGROUND

  • Avlonitis VS, Fisher AJ, Kirby JA, Dark JH. Pulmonary transplantation: the role of brain death in donor lung injury. Transplantation. 2003 Jun 27;75(12):1928-33. doi: 10.1097/01.TP.0000066351.87480.9E.

    PMID: 12829889BACKGROUND

  • Christie JD, Kotloff RM, Pochettino A, Arcasoy SM, Rosengard BR, Landis JR, Kimmel SE. Clinical risk factors for primary graft failure following lung transplantation. Chest. 2003 Oct;124(4):1232-41. doi: 10.1378/chest.124.4.1232.

    PMID: 14555551BACKGROUND

  • Thabut G, Vinatier I, Stern JB, Leseche G, Loirat P, Fournier M, Mal H. Primary graft failure following lung transplantation: predictive factors of mortality. Chest. 2002 Jun;121(6):1876-82. doi: 10.1378/chest.121.6.1876.

    PMID: 12065352BACKGROUND

  • Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.

    PMID: 16210116BACKGROUND

  • de Perrot M, Snell GI, Babcock WD, Meyers BF, Patterson G, Hodges TN, Keshavjee S. Strategies to optimize the use of currently available lung donors. J Heart Lung Transplant. 2004 Oct;23(10):1127-34. doi: 10.1016/j.healun.2003.09.010. No abstract available.

    PMID: 15477105BACKGROUND

Related Links

MeSH Terms

Conditions

Brain DeathPulmonary EdemaHypoxia

Interventions

AlbuterolSodium Chloride

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Lorraine B. Ware M.D.
Organization
Vanderbilt University
lorraine.ware@vanderbilt.edu
615 322 8614

Study Officials

  • Lorraine B Ware, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Michael A Matthay, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Megan Landeck, RN, BSN, APC

    California Transplant Donor Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 1, 2006

First Posted

April 3, 2006

Study Start

April 1, 2007

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

March 16, 2018

Results First Posted

September 2, 2013

Record last verified: 2018-02

Locations

US(1)