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

Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor 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.

Study Overview

• Status: Completed
• Conditions: Brain Death

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

DNC Organ Donor managed by Lifebanc

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of organs transplanted per donor	At 24 hours after transfering the donor to operating room.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of organs with targeted end-organ function per donor	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.	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		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	During donor management until cardiac arrest at the operating room
Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.		During donor management until cardiac arrest at the operating room

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Tissue Oxygen Saturation; Management of the DNC Organ Donor
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Death; Unconsciousness; Consciousness Disorders; Coma; Brain Death
• Other Study ID Numbers: 13-020 (Fox Chase Cancer Cener)