Organ Donor Tissue Oxygen Saturation as a Predictor of Number of Organs to Transplant Per Donor
This study is currently recruiting participants.
Verified March 2014 by The Cleveland Clinic
Information provided by (Responsible Party):
Silvia Perez-Protto, MD, The Cleveland Clinic
First received: March 19, 2013
Last updated: March 8, 2014
Last verified: March 2014
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.
||Time Perspective: Prospective
||Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor
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
- 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.
- 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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||15 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
DNC Organ Donor managed by Lifebanc
- DNC organ donor
- Age ≥ 15 years old
- Weight ≥ 45 Kg
- Donor after circulatory determination of death
- Living donor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819116
|Cleveland, Ohio, United States, 44195 |
|Contact: Silvia Perez Protto, MD 216-445-3276 firstname.lastname@example.org |
|Principal Investigator: Silvia Perez Protto, MD |
The Cleveland Clinic
||Silvia Perez-Protto, MD
||The Cleveland Clinic
||Daniel Lebovitz, MD
||Akron Children Hospital - Lifebanc
||J. Steven Hata, MD
||The Cleveland Clinic
No publications provided
||Silvia Perez-Protto, MD, M.D., The Cleveland Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2013
||March 8, 2014
||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:
ClinicalTrials.gov processed this record on April 17, 2014
Central Nervous System Diseases
Nervous System Diseases