Management of the Potential Organ Donor

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Management of the Potential Organ Donor

• Kenneth E. Wood, D.O.
• Professor of Medicine and Anesthesiology
• Senior Director of Medical Affairs
• Director of Critical Care Medicine and
  Respiratory Care
• The Trauma and Life Support Center
• University of Wisconsin Hospital and Clinics

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DisclaimerNo Financial SupportSlides Available
by Requestkew_at_medicine.wisc.edu
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Maximal Utilization and Optimal Management of
Potential Organ Donors

• Surveillance to identify patients with severe
  neurologic injury likely to progress to brain
  death
• Standardized method for brain death declaration
• Uniform request for consent
• Optimal medical management of donor

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Optimal Medical Management of the Potential Organ
Donor

• Continued intensity of support
• Focus shift from cerebral protective strategies
  to optimizing donor organs for transplantation
• Simultaneous critical care to organs of multiple
  patients
• Critical period
• Facilitates donor somatic survival
• Maintains organs to be procured best condition
• Donor management impact recipient function

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Role of Clinical Care Team in Donation

• Donor Medical Management Critical Care
  Management
• Integrative multi-disciplinary collaborative
  approach between OPO and Clinical Care Team

• Intensivists
• Pulmonary Consultants
• Cardiac Consultants
• Nursing
• Respiratory

• Hemodynamics
• Ventilatory Management
• Echocardiography
• Diagnostic Procedures

• Donor Management Team/Defined Champions
• Donor Family Support

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Cardiac Transplant Continuum
Mechanism

• Catecholamine
• Hypothesis

• Autonomic Surge
• MVO2 supply demand imbalance

• Endocrinopathy
• ? Coronary perfusion
• Aerobic ? Anerobic

NEURO INJURY
BRAIN DEATH
DONOR

• Fluids
• Immunomodulators catecholamines
• Vasopressin
• Thyroid hormone
• Steroids
• Insulin

Approach

• Standard

• Pretreatment ?
• Sympathetic antagonists
• Calcium blockers
• Cardiac sympathectomy

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Improvement of Donor Myocardial Function After
Treatment of Autonomic Surge During Brain Death

• Defined by Systolic BP gt 200 mmkg and tachycardia
  gt 140 beats/min.
• Observed in 63
• Duration 1.2 hours (30 min-6hr)
• Followed by ? BP which never occurred when AS
  absent

• AS less with head injury
• Treated with esmolol, urapidil or nicardipine
• Treatment independently associated with EF gt 50

Audibert Transplantation 2006821031-1036
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Complications of Brain Death and Impact on Organ
Retrieval

• hypothesized that brain death related
  complications would have no effect on the number
  of organs donated if an aggressive donor
  management protocol was in place.

• Vasopressor requirement 97.1
• Coagulopathy 55.1
• Thrombocytopenia 53.6
• Diabetes Insipidus 46.4

• Cardiac ischemia 30.4
• Lactic acidosis 24.6
• Renal failure 20.3
• ARDS 13

Salim Am Surgeon 200672377-381
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Aggressive Donor Management and Organ Donor
Shortage
Salim 200661429-435
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Transforming Unacceptable Donors
Potential Multi-organ Donors (150)
Acceptable 65 (98)
Unacceptable 35 (52)

• MAP gt 60 mmHg
• CVP lt 12 mmHg
• PCWP lt 12 mmHg
• LVSWI gt 15 gm
• Inotropes lt 5 ug/Kg/mm

• 40 (21) MAP lt 55 (mean 47 mmHg) despite
  inotropic support
• 19 (10) CVP gt 15 (mean 18 mmHg)
• 4 (2) inotropes gt 20 (mean 25 ug/Kg/min)
• 25 (13) PCWP gt 15 (mean 20 mmHg)
• 12 (6) LVSWI lt 15 (mean 12.8 gm)

Outcomes
Optimum Management

• Invasive monitoring
• Bolus steroids (15mg/Kg/MP)
• Insulin/glucose
• Argine vasopressin 1U bolus and 1.5 U/hr
• Tri-iodothyronine 4 ug bolus and 3 ug/hr

• 44/52 unacceptable donors yielded
  transplantable organs
• 84 alive (13-48 months)
• 92 of initially unacceptable organs were capable
  of functional resuscitation

Wheeldon J Heart Lung Txp 1995 14734-742
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Donor Management TrialHormonal Therapy
Randomization
T3 0.8 ug/Kg Bolus Followed by 0.113 µg/Kg/hr
T3 And Methyl-prednisolone
Placebo
Methyl-prednisolone 1000 mg Bolus
Venkateswaran Eur Heart J 2009
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Hemodynamic Effects of Adjunctive Hormonal Therapy
Marginal
Functional

• MAP lt 70 mmHg
• with
• CVP or PCWP gt 14 mmHg
• and
• CI lt 2.4 L/min
• Dopamine gt 5 µg/Kg/min
• or
• Norepi gt 0.06 µg/Kg/min
• or
• Epi gt 0.03 µg/Kg/min

• CVP lt 12 mmHg
• PCWP lt 14 mm Hg
• CI gt 2.5 L/min
• Minimal vasoactive support
• No gross LVH or palpable CAD on inspection

Brain Stem Death (80)

• Trauma 24
• Vascular event/tumor 64
• Hypoxia/Infection 13

Management
Brain Death Coning
OR
Consent
Management
HRT
Retrieval
1 hr
5.9 hrs
10.7 hrs
2 hrs
12.7 hrs
6.9 hrs
19.6 hrs
Venkateswaran Eur Heart J 2009
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Hemodynamic Parameters for Entire Trial Cohort
Venkateswaran Eur Heart J 2009
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Cardiac Index and Treatment
Venkateswaran Eur Heart J 2009
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Donor Heart Function and Thyroid Function

• 58 Low free T3 or T4
• 18 co-existent low TSH
• Initial CI no different with low T3 or T4
• CI ? regardless of initial T3 or T4 or T3 Tx

Venkateswaran Eur Heart J 2009
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Cardiac Index and Pre-Tx Thyroid
Venkateswaran Eur Heart J 2009
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Donor Heart Function and Norepinephrine

• Association between NE withdrawal and cardiac
  functional improvement
• 60 (48/80) initially receiving NE
• Significantly lower LVSWI (43.5 vs 36.6)
• Vasopressin introduced 60/80 ? NE withdrawn in
  26/48 or reduced to 0.06 µg/Kg/min

Norepi
Vasopressin
CI 3.18 3.72
SVR 1190 964
Venkateswaran Eur Heart J 2009
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Hemodynamic Effects of Adjunctive Hormone Therapy
Trial Donors (80)
50 Non-Marginal at Initial Assess (40)
50 Marginal at Initial Assess (40)

• 35 Unsuitable at End Assessment (14)
• CAD (5)
• RV Dysfunction (5)
• LV Dysfunction (4)

65 Suitable at End Assessment (26)
35 Suitable at End Assessment (14)

• 65 Unsuitable at End Assessment (26)
• CAD (15)
• RV Dysfunction (6)
• LV Dysfunction (5)

58 Retrieved for TXP (15)
71 Retrieved for TXP (10)
Total Suitable at End Assessment (40)

• 37 Non-Txp (15)
• No Recipient (10)
• Age gt 60 (3)
• Poor Donor Txp (2)

63 Hearts Txp (25)
Venkateswaran Eur Heart J 2009
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Donor Management

• Active donor management improves circulatory
  function and has the capacity to increase the
  yield of suitable hearts from the existing pool
  of potential donors. Neither T3 nor MP, alone or
  in combination, appears fundamental to this
  improvement.

Venkateswaran Eur Heart J 2009
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Donor Management

• Our study demonstrates that not only may donor
  circulatory status be improved by active
  management but also there is the potential to
  increase the yield of transplantable hearts if
  decisions on organ acceptance are deferred until
  a period of resuscitation and assessment is
  complete. Active donor management with PAFC
  monitoring is the cornerstone of this objective
  but this has implications for planning donor
  retrieval services. The simple introduction of
  hormone therapy is not a substitute for the
  detailed haemodynamic assessment and management
  of the potential heart donor.

Venkateswaran Eur Heart J 2009
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Role of Brain Death in Donor Lung Injury
Neurogenic Pulmonary Edema

• Blast Injury Theory ? Hemodynamic mechanism
• Sympathetic surge
• Transient massive ? hydrostatic pressure with
  structural damage to capillary endothelium
• Sympathetic alteration of capillary permeability
• Cytokines ? TNF? IL-1 activate endothelial cells
  to express adhesion molecules and mediate
  production of IL-8 ? neutrophil activator ? bind
  to endothelial cells ? migrate to
  interstitium/alveolar spaces ? release ROS and
  proteolytic enzymes

? SVR ?CO ?LAP
Left
? Pvc ? VR ?PAP ?Pul Volume
Right
Inflammatory Response
Alvonitis Trasnaplantation 2003 751928-1933
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Potential Lung Donor
Unacceptable Lungs
Marginal Lungs
Ideal Lungs

• PaO2/FiO2 gt 300
• PEEP 5cmH2O
• Clear chest x-ray
• Age lt 55
• Tobacco lt 20 pk/yr
• Absence of trauma, surgery, aspiration,
  secretions, malignancy purulent secretions

Baseline Status
Acquired reversible
Alveolar Flooding
Aspiration
Atelactasis
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Impact of Donor Management Protocol on Lung
Donation and Recipient Outcomes
Education

• Transplant Pulmonologists and OPO staff training
  sessions on Donor selection and management
• Emphasis upon every donor as a lung donor
• Request and consent should be attempted for every
  donor
• Education regarding donor management strategies

Angel AJRCCM 2006174710-716
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Impact of Donor Management Protocol on Lung
Donation and Recipient Outcomes
Active Management

• Recruitment Maneuvers
• Pressure control ventilation 25 cm H2O and PEEP
  15 cm H2O for 2 hours
• Switch to conventional volume control mode with
  TV 10 ml/kg and PEEP 5 cm H2O
• Fluid balance
• Minimized use of crystalloids
• Diuretics to maintain neutral or negative balance
• Aspiration risk
• Elevated head of bed to 300
• Inflate ET balloon to 25 cm H2O
• Bronchosopy with BAL to eval CXR area of
  infiltrate

Angel AJRCCM 2006174710-716
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Impact of Donor Management Protocol on Lung
Donation and Recipient Outcomes
Absolute
Extended

• PaO2/FIO2 gt 300
• No infiltrates
• No copious purulent secretions
• No bronchoscopically demonstrated aspiration

• Age gt 55 years
• Pack years gt 20
• History of pulmonary disease
• Severe chest trauma
• Mechanical ventilation gt 4 days
• Positive gram stain of tracheal or BAL fluids

• Ideal
• All absolute criteria
• No extended criteria
• Extended
• All absolute criteria
• One or more extended criteria
• Poor
• Did not satisfy ALL absolute criteria

Poor Ideal Poor Extended
Angel AJRCCM 2006174710-716
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Impact of Donor Management Protocol on Lung
Donation and Recipient Outcomes
Angel AJRCCM 2006174710-716
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Impact of Donor Management Protocol on Lung
Donation and Recipient Outcomes
Angel AJRCCM 2006174710-716
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Early Donor Management Increases Retrieval Rate
of Lung for TXP
TRIAL
NON - TRIAL
Timing Within 2 hrs Consent Continued for 6.9 hrs OR
Protocol optimization for vent/hemodynamics Active management using protocols by on site team Standard ICU approach
Pul Art. Cath 2 hours post consent OR
Fem A Line 2 hours post consent OR
EVLWI Measured None
PVPI Calculated None
Bronchoscopy Early OR
Trial Meds 1 hour into management OR
Venkateswaran Ann Thorac Surg 2008 85 278-86
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Early Donor Management Increases Retrieval Rate
of Lungs for TXP
Management Points

• Commenced Management
• 2 hours post consent
• 12.5 hours post brain death and continued for 6.9
  hours
• Respiratory Management
• Bronchoscopy early
• TV 10 ml/Kg PEEP 5 cm H2O
• Frequent Suctioning
• Volume recruitment by turning every 2 hours
• Active hemodynamic management
• Specific algorithms for
• CI gt 2.5 L/min m2
• CVP and PCWP lt 12 mm Hg
• MAP 65-85
• SVR 800-1200 dynes/cm/sec-5 ? vasopressin
• Fluid Resuscitation
• Small amount blood (Hgb gt 10 g/dl), gelatin or
  colloid

Venkateswaran Ann Thorac Surg 2008 85 278-86
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Early Donor Management Increases Retrieval Rates
of Lungs for TXP
Management Outcomes

• Respiratory function deteriorated
• ? PaO2/FIO2
• ? EVLWI and PVPI
• PaO2/FIO2 rose after final inspection
• Bronchoscopy
• Abnormalities in 20 donors
• BAL positive cultures in 31 donors
• Methylprednisolone
• No effect on any absolute indicator
• Associated with reduced accumulation of EVLWI and
  lower pre-retrieval PCWP
• Did not improve EVLWI in marginal
• Norepinephrine ? PaO2 / FIO2 ratio deteriorated
  and EVLWI increased significantly NOT prevented
  by withdrawal of NE

Venkateswaran Ann Thorac Surg 2008 85 278-86
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Early Donor Management Increases Retrieval Rate
for Lungs for TXP
Potential Lung Donors (182)
Trial Lungs (120)
Non Trial Lungs (244)
MP(30)
T3 MP(28)
T3 (34)
Placebo (28)
Non-MP Lungs (62)
MP Donors (58)
35.5 Lungs Retrieval (22/62)
44.8 Lungs Retrieval (26/58)
27 Lungs Transplanted (66/244)
40 Lungs Transplanted (48/120)
Venkateswaran Ann Thorac Surg 2008 85 278-86
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Early Donor Management

• Although nontrial donor care was based on a
  similar management protocol, albeit without
  bronchoscopy or invasive monitoring, management
  was overseen by donor procurement coordinators,
  who are simultaneously engaged in a logistic
  process that includes acquisition of consent,
  donor family support, offering of organs to
  recipient centers, arranging the multiorgan
  retrieval procedure, and transportation of organs
  and tissue. In contrast, the donor research
  fellow was wholly dedicated to donor management,
  and we would suggest that this dedicated donor
  management role is fundamental to maximize yield.

Venkateswaran Ann Thorac Surg 2008 85 278-86
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3.75 OPD

• Subtle Changes or Paradigm Shift?
• Joseph Kambe, M.D.

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Improving What We Do.

• There are short term goals and long term goals.
• 3.75 Organs per Donor is a short term goal.
• Multiple hospitals have shown this is attainable.
• In reality, by paying attention to detail.
• Why it happened is not so clear.
• Improved because we were looking?
• Is it sustainable across multiple institutions?

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Donor Management Goals

• If all are met, great results.
• If only some are met, variable results.
• As an example CVP and C.O. (BP).
• If you met the CVP goal and not use pressors.
• Does this mean you did something useful?
• Or does it mean that the cardio/pulmonary axis
  was intrinsically good anyway? Or both?

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How Useful is a CVP?

• What affects the CVP?
• Volume?
• Cardiac Status?
• Pulmonary Status?
• Fluids being infused?
• Patient position?
• Who does the measurement?
• Vasomotor tone?

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The Computer CVP 17
Would you diurese this patient?
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CVP should estimate dLVP
CVP will be falsely high. Positive pressure
ventilation. PEEP. Pulmonary disease.
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The Clinical Picture

• PEEP 12 cm H2O.
• BP 105/50 mmHg.
• CI 2.3 l/min/m2.

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Vasoactive Drugs - Goals

• Blood Pressure or Cardiac Output or Both.
• One organ perfuses by pressure alone.
• HEART diastolic root pressure - ventricular wall
  tension.
• Increase myocardial O2 Consumption
• All other organs are cardiac output dependent.
• There is a point where pressure comes at the
  expense of perfusion.

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Vasoactive Drugs

• Dopamine
• Highest incidence of arrhythmias, organ
  dysfunction, death.
• Causes norepinephrine release from the storage
  granules in the synapse.
• Does not increase renal blood flow.
• Acts as the antagonist to Renin-Angiotension.
• Recent articles in CCM argue that it should not
  be used.

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Norepinephine

• Activity depends on the number of alpha and beta
  receptors in the target organ.
• Under stimulation receptors are used up.
• Only vasoactive drug we do not dose by weight.
• Why I know not.

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Neosynephrine

• Pure alpha agonist.
• Causes peripheral vasoconstriction.
• In neurogenic shock there is peripheral
  vasoconstriction and cardiac depression.
• After-load increase increased wall tension.

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Hormone Replacement
N 701 Historical Control Non-Hormone Replacement Hormone Replacement
Age lt 40 3.8 opd 4.2 opd
Age gt 40 2.5 opd 3.1 opd
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So, Why Is this Controversial?

• Repeating this has been difficult/impossible.
• Used T3, most of us use T4.
• These patients were all fed.
• The Company says T4 is not stable in D5W.
• The Company says T4 is not stable as an infusion.
• As of now there is no data about these issues
  from the Company.

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Conversion of T4

• T4 is not the active hormone.
• T4 must be converted to T3 in the periphery.
• This conversion is decreased in illness.
• May take up to 8 hours.
• Has an immediate action on vasomotor tone.

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Actions of T3
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Intracellular T3 Activity
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T3 Action in the Nucleus

• Increases RNA transcription/protein synthesis.
• Increases Glucose and protein metabolism.
• Where does the fuel for this come from?
• Remember in the original article, all were fed.
• We have lost the ability to convert fat into
  glucose.
• Burning intrinsic protein to make energy.
• In illness, studies show giving T4.
• Increases organ dysfunction and mortality.

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Furthermore

• How critical is the 6 8 hour delay in T3
  function in terms of repair (protein synthesis)?
• Should we all be using T3?
• In terms of protein metabolism.
• Robbing Peter to pay Paul.
• Protein breakdown to generate energy.
• Given the Companys guidelines.
• Are we even giving adequate amounts?

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So. What to Make of This?

• If we are going to use parameters.
• Education. Everyone needs to do it the same way.
• Does it matter? How are we going to find out?
• What to do about hormone replacement?
• Do we need to upgrade our technology?
• There are noninvasive ways to measure C.O.
• Other ways to estimate LV filling pressure.

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Plea for a National Database.

• Old medical axiom WNL we never looked.
• If you dont measure it, you cant improve it.
• Critical Care has spend a lifetime looking.
• DMGs are a beginning to this end.
• We need to refine these.
• The larger the numbers the better the accuracy.

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DONOR MANAGEMENT GOALSMoving Toward a National
StrategyNIL Get Connected WebinarOctober 13,
2009

• Darren Malinoski, MD
• Assistant Professor of Surgery
• Director, Surgical Intensive Care Unit
• Chair, Organ Donor Council
• University of California, Irvine

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BACKGROUND

• Donor Management Forum August 2009
• Intensivists, Transplant Surgeons, OPO
  representatives, National Organizations
• Four predominant REQUESTS
• Increase Intensivist involvement
• Increase the science of donor management
• Tie donor management data to SRTR outcomes
• Funding for research

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PLAN FOR THIS SESSION

• Background on Donor Management Goals (DMGs)
• Region 10
• Region 5 DMG initiative
• Survey Monkey results
• National DMG initiative

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OTPD and DMGs
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CONSENSUS 1 -- 4

• Sodium lt 155
• MAP gt 60
• pH 7.25 7.5
• CVP lt 10
• (or serum osmolality 285 295)

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CONSENSUS 5 6

• Pressors 1 or none
• (one pressor plus Vasopressin
• to treat DI is OK)
• pO2 gt 300 if on 100 O2
• ( or a P/F ratio gt 3)

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RESULTS FULL YEAR 2008

• 774 TOTAL CASES
• 264 Met Criteria 34
• 510 Did not meet criteria 66

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DONOR MANAGEMENT GOALSThe Region 5 DMG
ProjectPart 1 RetrospectivePart 2
Prospective
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PROPOSED DMGS for REGION

• 1. MAP 60-100 2.      CVP 4-10 3.      EF
  gt 50 4.      lt/ 1 pressor used AND
  a.      Dopamine lt/ 10 mcg/kg/min
• b.      Neosynephrine lt/ 100 mcg/kg/min
  c.      Norepinephrine lt/ 10 mcg/kg/min
  d.      Vasopressin lt/ 2.4 units/hour (0.04
  units/min)
• 5.      ABG pH 7.3-7.45
• 6.      Pao2Fio2 ratio  gt300 on PEEP 5
  7.      Serum Sodium 135-160 8.      Urine
  output 1-3 cc/kg/hour 9.      Glucose lt 150
  10. Hemoglobin gt 10
• Track hormone replacement usage

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PART 1 - RETROSPECTIVE

• Universal template
• 40 SCDs from each OPO
• Retrospective collection of data regarding
  proposed DMGs (prior to procurement) and organ
  disposition information
• Statistical analyses
• 80 DMGs goal met
• gt/ 4 OTPD primary outcome measure
• DMG-specific results
• Other notable findings

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DMGS AND OTPD

• Mean DMGs with gt/ 4 OTPD 7.2
• Mean DMGs with lt 4 OTPD 6.1
• T-test plt0.001
• When goals met
• Mean OTPD 4.4
• 70 gt/ 4 OTPD
• When goals not met
• Mean OTPD 3.3 (t-test, plt0.001)
• 39 gt/4 OTPD (Pearsons Chi-square, plt0.001)

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Multivariate analysis - gt/ 4 OTPD
Variable OR 95 CI p value
age 0.95 0.93-0.97 lt0.001
CVP 4-10 1.7 0.96-3.1 0.071
EF gt 50 4.5 2.5-8.3 lt0.001
lt/1 pressor 1.006 0.51-1.98 0.986
PF gt 300 4.8 2.6-8.6 lt0.001
Na 135-160 2.7 0.99-7.4 0.053
Thyroid hormone 1.7 0.97-3 0.067
Serum creatinine 0.612 0.4-0.93 0.022
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Moving Forward Current Project

• MAP gt 60
• CVP 4-10
• EF gt 50
• lt/ 1 pressor and low dose (vasoP eliminated)
• pH 7.3-7.45
• PF gt 300
• Sodium 135-155
• Glucose lt 150
• UOP 1-3 cc/kg/hr over preceding 4 hours

• The Region agreed on 9 DMGs to prospectively
  implement and track for 6 months.
• DMGs will be measured at consent, 12-18 hours
  later, and prior to going to OR
• OTPD and graft outcome data will be analyzed

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General Data

• Part 1
• 320 donors
• 100 SCD
• DMGs prior to OR
• Purely retrospective data
• DMGs met 8/10

• Part 2 July-Dec 2008
• 492 donors
• 380 (77) SCD
• DMGs at 3 time points
• Prospective implementation
• DMGs met 7/9
• Graft Function Data

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Can we make a difference or is fate sealed before
we start?
DMG data (SCDs only n255) lt4 OTPD (n132) gt/4 OTPD (n123) p value
DMGs at consent (1) 4.5 5 0.001
DMGs at 12-18 hrs (2) 5.1 6.1 lt0.001
DMGs prior to OR (3) 5.5 6.3 lt0.001

Delta DMG 1-2 0.71 1.1 0.050
Delta DMG 2-3 0.3 0.19 0.522
Delta DMG 1-3 1 1.3 0.210
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Multivariate analysis Part 2gt/ 4 OTPD (n376,
4 missing)
Variable OR 95 CI p value
Age 0.95 0.93-0.96 lt0.001
Terminal creatinine 0.74 0.6-0.9 0.004
DMG 1 met 1.9 1.02-3.7 0.044
DMG 2 met 1.6 0.92-2.6 0.097
DMG 3 met 2.2 1.3-3.6 0.002

Ejection fraction 3 3.3 1.8-6 lt0.001
Pao2Fio2 3 3.2 1.6-6 0.001
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PART 2 CONCLUSIONS

• DMGs are still associated with OTPD
• Changes in DMGs over time are associated with
  OTPD
• Pre-donor management is associated with outcomes

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SURVEY MONKEY RESULTS

• 41 OPOs responding

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Does your OPO use DMGs?
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Does your region have a uniform DMG initiative?

• 38 responses
• YES 25 (66)
• NO 13 (34)
• More than one response from 9 regions
• One response from region1
• No response from region 6

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If your region does not have uniform DMGs, would
you be willing to do so?
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Would your OPO be interested in participating in
a National DMG Project?
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How important is a National DMG initiative for
advancing the science of donor care?
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CONCLUSIONS

• REGION 10
• Retrospective Meeting all six DMGs prior to
  the OR ? more OTPD
• REGION 5
• Retrospective and Prospective data suggest that
  meeting DMGs throughout case ? more OTPD
• National Survey suggests strong support for DMGs
  and a donor database

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Future Directions

• Refine DMGs
• Develop Web-based data entry system
• Create national DMGs and donor database
• Continue to engage intensivist community
• Create a network for large-scale research