An observational study in Brain Death, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-01-27.
Sponsored by The Cleveland Clinic · Observational
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.
Specifically the study aims to:
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.
74 studies on the registry are indexed under Brain Death; 9 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 35 observational studies indexed under Brain Death.
Browse Brain Death studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
DNC Organ Donor managed by Lifebanc
Exclusion Criteria:
Number of organs transplanted per donor
Time frame: At 24 hours after transfering the donor to operating room.
Number of organs with targeted end-organ function per donor
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.
Time frame: At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.
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.
Correlation of tissue oxygenation readings to macro-hemodynamic measurements
Mean arterial pressure, central venous pressure, cardiac output, positive pressure variation, stroke volume variation
Time frame: During donor management until cardiac arrest at the operating room
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
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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