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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Silvia Perez-Protto, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01819116
First received: March 19, 2013
Last updated: March 8, 2014
Last verified: March 2014
  Purpose

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
Brain Death

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Number of organs transplanted per donor [ Time Frame: At 24 hours after transfering the donor to operating room. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.

  • 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. ] [ Designated as safety issue: No ]
  • Correlation of tissue oxygenation readings to macro-hemodynamic measurements [ Time Frame: During donor management until cardiac arrest at the operating room ] [ Designated as safety issue: No ]
    Mean arterial pressure, central venous pressure, cardiac output, positive pressure variation, stroke volume variation

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819116

Contacts
Contact: Silvia E Perez-Protto, MD 216-712-2369 perezs2@ccf.org
Contact: Daniel Lebovitz, MD dlebovitz@lifebanc.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Silvia Perez Protto, MD    216-445-3276    perezs2@ccf.org   
Principal Investigator: Silvia Perez Protto, MD         
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

No publications provided

Responsible Party: Silvia Perez-Protto, MD, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01819116     History of Changes
Other Study ID Numbers: 13-020, xx
Study First Received: March 19, 2013
Last Updated: March 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Tissue Oxygen Saturation
Management of the DNC Organ Donor

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

ClinicalTrials.gov processed this record on July 22, 2014