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

Brain Death Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819116
• Other study ID #: 13-020
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: January 26, 2016
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Death

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of organs transplanted per donor		At 24 hours after transfering the donor to operating room.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.		During donor management until cardiac arrest at the operating room	No