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

Completed

• Conditions: Brain Death

• Registration Number: NCT01819116
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Study Start: 2013-04
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of organs transplanted per donor	At 24 hours after transfering the donor to operating room.

Secondary Outcome Measures

Name	Time	Method
Correlation of tissue oxygenation readings to macro-hemodynamic measurements	During donor management until cardiac arrest at the operating room	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.	During donor management until cardiac arrest at the operating room
Number of organs with targeted end-organ function per donor	At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.	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.
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States