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NCT Number: NCT01819116

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

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Specifically the study aims to:

  • Evaluate the association between StO2 level in the DNC organ donor and the number of organs transplanted per donor;
  • Evaluate whether or not tissue perfusion in the DNC organ donor population correlates with currently measured macro-hemodynamic variables during the donor management phase.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DNC organ donor
  • Age ≥ 15 years old
  • Weight ≥ 45 Kg

Exclusion criteria

  • Donor after circulatory determination of death
  • Living donor

Treatment and study plan

Primary outcomes

  1. Number of organs transplanted per donor

    Time frame: At 24 hours after transfering the donor to operating room.

Secondary outcomes

  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

    • Kidney function: Creatinine ≤ 1.5 mg/dL, urinary output ≥ 0.5 ml/kg/h
    • 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.
    • Lung function: PaO2/FiO2 index ≥ 300 with PEEP ≤ 8 (oxygen challenge gas)
    • 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
    • Pancreatic function: HbA1c<6, amylase and lipase within normal range per laboratory limits.
    • 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2013
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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