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Organ Donor Tissue Oxygen Saturation as a Predictor of Number of Organs to Transplant Per Donor

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ClinicalTrials.gov Identifier: NCT01819116
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to quantify the association between tissue oxygen saturation (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ donor and the number of organs transplanted per donor.

Condition or disease
Brain Death

Detailed Description:

Specifically the study aims to:

  1. Evaluate the association between StO2 level in the DNC organ donor and the number of organs transplanted per donor;
  2. Evaluate whether or not tissue perfusion in the DNC organ donor population correlates with currently measured macro-hemodynamic variables during the donor management phase.
  3. Assess if StO2 in the DNC organ donor is related to the number of organs with normal end-organ function, and with the number of organs predicted to be transplanted using the organ donor calculator.
  4. Assess if StO2 in the DNC organ donor is related with intravenous thyroid hormone treatment.

Investigators will conduct an observational study, including 60 DNC organ donors, in Lifebanc's Donor Service Area (DSA). Investigators will monitor and record blindly the StO2 with near-infrared spectroscopy (NIRS) in the DNC organ donor from the beginning of the OPO (Organ Procurement Organization) organ donor management period until cardiac arrest in the operating room at the time of recovery.


Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor
Study Start Date : April 2013
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Number of organs transplanted per donor [ Time Frame: At 24 hours after transfering the donor to operating room. ]

Secondary Outcome Measures :
  1. Number of organs with targeted end-organ function per donor [ Time Frame: At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room. ]

    Normal end-organ function definitions

    1. Kidney function: Creatinine ≤ 1.5 mg/dL, urinary output ≥ 0.5 ml/kg/h
    2. Liver function: INR <1.5, Prothrombin time: 8.4-13 seconds (or within normal range per testing lab). Bilirubin, AST, ALT within normal range per laboratory limits.
    3. Lung function: PaO2/FiO2 index ≥ 300 with PEEP ≤ 8 (oxygen challenge gas)
    4. Heart function: Normal systolic and diastolic function per echocardiogram with minimal inotropic/vasopressor support. Systolic function will be estimated by ejection fraction and/or shortening fraction on echocardiogram. Normal cardiac catheterization data if available
    5. Pancreatic function: HbA1c<6, amylase and lipase within normal range per laboratory limits.
    6. Small intestine function: lactate ≤ 2.2 mmol/L with minimal vasopressor support.

  2. Number of organs predicted to be transplanted using organ donor calculator [ Time Frame: At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room. ]
  3. Correlation of tissue oxygenation readings to macro-hemodynamic measurements [ Time Frame: During donor management until cardiac arrest at the operating room ]
    Mean arterial pressure, central venous pressure, cardiac output, positive pressure variation, stroke volume variation

  4. Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued. [ Time Frame: During donor management until cardiac arrest at the operating room ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
DNC Organ Donor managed by Lifebanc
Criteria

Inclusion Criteria:

  1. DNC organ donor
  2. Age ≥ 15 years old
  3. Weight ≥ 45 Kg

Exclusion Criteria:

  1. Donor after circulatory determination of death
  2. Living donor
Contacts and Locations

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): NCT01819116


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Silvia Perez-Protto, MD The Cleveland Clinic
Study Director: Daniel Lebovitz, MD Akron Children Hospital - Lifebanc
Study Director: J. Steven Hata, MD The Cleveland Clinic
More Information

Responsible Party: Silvia Perez-Protto, MD, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01819116     History of Changes
Other Study ID Numbers: 13-020
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: March 2014

Keywords provided by Silvia Perez-Protto, MD, The Cleveland Clinic:
Tissue Oxygen Saturation
Management of the DNC Organ Donor

Additional relevant MeSH terms:
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes