Clinical trial NCT01819116: Organ Donor Tissue Oxygen Saturation as a Predictor of Number of Organs to Transplant Per Donor
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: Tissue Oxygen Saturation
Management of the DNC Organ Donor
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DNC Organ Donor managed by Lifebanc

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.

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 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

Primary outcomes:
measure: Number of organs transplanted per donor
timeFrame: At 24 hours after transfering the donor to operating room.
Secondary outcomes:
measure: Number of organs with targeted end-organ function per donor
timeFrame: At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.
measure: Number of organs predicted to be transplanted using organ donor calculator
timeFrame: At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.
measure: Correlation of tissue oxygenation readings to macro-hemodynamic measurements
timeFrame: During donor management until cardiac arrest at the operating room
measure: Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.
timeFrame: During donor management until cardiac arrest at the operating room
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Silvia Perez-Protto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akron Children Hospital - Lifebanc
name: Daniel Lebovitz, MD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: J. Steven Hata, MD
role: STUDY_DIRECTOR
References: