10 - P.van Der Linden - The Role of Artificial Colloids in Paediatric Fluid Resuscitation

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    TheThe RoleRole ofof ArtificialArtificial ColloidsColloids inin PediatricPediatric

    uu esusc a onesusc a on

    ,

    CHU Brugmann-HUDERF, Free University of Brussels

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    Intraoperative: the 4-2-1 rule with isotonic crystalloids; glucose onlyfor high-risk populations (i.e. neonates)

    Immediate postop period: 2/3 of the calculated volume with isotonic

    crystalloid. Subsequent fluids: Glu 5% NaCl 0.45%

    From Bailey AG et al. Anesth Analg 110:375-90, 2010.

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    ,

    monitored goal-directed combination of both crystalloid andcolloid therapy, similar to that occurring in adult surgical patients

    Rather than extrapolating adult and animal data to asuscep e popu a on, researc s ou e rec e owar

    safety and outcomes of synthetic colloid use in children

    From Bailey AG et al. Anesth Analg 110:375-90, 2010.

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    Parameters Predicting Fluid Responsiveness in

    Postoperative Cardiac Surgery Children

    children after VSD repair

    Res irator variations of transthoracic echo-derived

    parameters:Aortic blood flow velocity (Vpeak)

    10 ml/kg HES 130/0.4 over 20min

    Responders:stroke volume increase >15%

    0,83 (0,61-1,00): p=0.01

    0,85 (0,69-1,00): p=0.01

    0,48 (0,22-0,73) p=NS

    From Choi DY et al. Pediatr Cardiol 31:1166-70, 2010.

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    Colloids In Pediatric Sur ical Patients

    Studies are few in number and small in size

    Albumin has been considered the gold standard for

    maintenance of colloid osmotic pressure in infants and

    plasma expander in this population

    From Schwartz U. Anaesthesist 48:41-50, 1999.From Soderlind M et al. Paediatr Anaesth 11:685-9, 2001.

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    HES 130/0.42/6:1 For Perioperative

    Plasma Volume Replacement in Children

    From Smpelmann R et al. Pediatr Anaesth 18:929-33, 2008.

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    HES 130/0.42/6:1 For Perioperative

    Plasma Volume Replacement in Children

    No serious adverse drug reactions were observed

    From Smpelmann R et al. Pediatr Anaesth 18:929-33, 2008.

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    Perioperative Volume Replacement in Children

    Balanced Vs Unbalanced HES 130/0.42/6:1

    Unbalanced: 10 5 ml/kg (N=249)

    Balanced: 9 7 ml/kg (N=147)

    No serious adverse drug

    reactions were observed

    Smpelmann R et al. Pediatr Anaesth 20:100-4, 2010.

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    Effects of HES 130/0.4/9:1 on Clot

    Formation in Children

    Prospective randomized study - non cardiac surgery (N=42)

    Children (3-15 kg) assigned to receive 15 ml/kg of 5%a um n, mo e u ge a n or . :

    Changes after gelatin nearly equal to albumin Changes in coagulation time, clot formation time, angle, clot

    pronounced after HES

    From Haas T et al. Anaesthesia 62:1000-7, 2007.

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    Effects of HES 130/0.42/6:1 on Clot

    Formation in Children

    Prospective randomized study all surgeries (N=50)

    Children (3-50 kg) assigned to receive 10 ml/kg of 4%mo e u ge a n or . :

    Clot formation time Maximum clot elasticity

    No significant difference between gelatin and HES

    From Osthaus WA et al. Acta Anaesthesiol Scand 53:305-10, 2009.

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    Effects of HES 130/0.4 on Clot Formation in

    Children

    Different populations (age surgical procedures) ?

    Different pharmacokinetic properties (C2/C6 ratio) ?

    Haas T et al. Anaesthesia 2007 vs Osthaus WA et al. Acta Anaesthesiol Scand 2009.

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    HES130/0.4/9:1 Vs. Albumin in Young

    Children Undergoing Non-cardiac SurgeryPros ective randomized o en multicenter stud

    Children < 2 years undergoing non cardiac surgery (N=82)

    6% HES 130/0.4/9:1: 16.0 ml/kg.

    From Standl T et al. Eur J Anaesth 25:437-45, 2008.

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    HES130/0.4/9:1 Vs. Albumin in Young

    Children Undergoing Non-cardiac Surgery

    6% HES 130/0.4/9:1: 16.0 ml/kg

    5% Human albumin: 16.9 ml/kgComparable hemodynamic profile and COP

    From Standl T et al. Eur J Anaesth 25:437-45, 2008.

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    HES130/0.4 in Children Undergoing Surgery

    Relatively low volume of starch infused

    Low bleedin risk sur er

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    Albumin vs Crystalloids for Pump Priming

    in Cardiac Surgery

    Meta-analysis of controlled trials (adult and pediatric patients):21 studies, 1346 patients

    Albumin prime reduces:

    The on-bypass drop in platelet count

    pooled WMD: -23,8 10 /L [-42,8 to -4,7 10 /L]The colloid oncotic pressure decline

    - - -

    9 9

    , , ,

    The on-bypass positive fluid balance

    pooled WMD: -584 ml [-819 to -348 ml]e pos opera ve we g ga n

    pooled WMD: -1,0 kg [-0,6 to -1,3 kg]

    From Russel JA et al. J Cardiothorac Vasc Anesth 18:429-437, 2004.

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    um n: a s e v ence o n ca ene

    =

    No quantitative meta-analysis

    In cardiac surgery, albumin vs crystalloid administration:Higher colloid osmotic pressure

    Reduced ulmonar oedema

    Greater hemodilution

    n y pe a r c s u es: pa en s...

    From Haynes GR et al. Eur J Anaesthesiol 20:771-793, 2003.

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    Hetastarch vs Albumin

    for Postoperative Volume Expansion

    Randomized double-blind

    study (N=47)

    19

    Final PT (s)

    Children: 1 - 15.5 years

    Volume expansion "as 17

    18

    clinically indicated"- 5% albumin: 20.5 9.5 ml/kg- 6% hetastarch: 17.9 9.0 ml/kg

    16

    Clinical bleeding : NS14

    0 10 20 30 40

    13

    From Brutocao D et al. J Cardiothorac Vasc Anesth 10:348-351, 1996.

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    Fluid Management in Pediatric Cardiac Surgery:

    os - ypass

    Prospective randomized study

    Post-bypass fluids (10 ml/kg)

    20

    ml/kg (0-24 h)

    -

    - HES 130/0.4 (N=21) 15

    an ar ze antransfusion policy 10

    HES infusion prolonged INR

    (but not aPTT)

    5

    in comparison to FFP Blood loss RBCs FFP

    FFP HES

    From Chong Sung K et al. Acta Anaesthesiol Scand 50:108-111, 2006.

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    .Pros ective randomized observer-blinded stud N=119

    Fluid management: pre, per and postop: max 50ml/kg.d- um n group =- HES 130/0.4 6% group (N=60)

    First objective: calculated blood loss

    The stud was desi ned to demonstrate the e uivalence between 6% HES 130/0.4

    and 4% albumin regarding the calculated blood loss. Equivalence was defined as

    35 ml of pure RBCs. Assuming a SD of 62 ml, a total number of 55 patients in each

    rou had to be included to obtain a ower of 0.8 and a = 0.05

    From Hanart C et al. Crit Care Med 37: 696-701, 2009.

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    .Pros ective randomized observer-blinded stud N=119

    Fluid management: pre, per and postop: max 50ml/kg.d- um n group =- HES 130/0.4 6% group (N=60)

    First objective: calculated blood lossSecondary objectives:Allogeneic blood exposure

    Intra-operative fluid balance

    From Hanart C et al. Crit Care Med 37: 696-701, 2009.

    Non cyanotic disease

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    Non-cyanotic disease(CPB circuit: Dideco Inc, Mirandola, Italy)

    .

    Children stratified accordin to wei ht and the resenceor the absence of a cyanotic disease

    yano c seaseWeight Oxygenator Prime volume

    (ml)Albumin group HES group

    .4.7 12.0 kg Lilliput 2 550 10 1412.0 20.0 kg EOS I 750 5 520.0 35.0 kg EOS II 850 1 2

    Non-cyanotic disease

    Weight Oxygenator Prime volume

    (ml)

    Albumin group HES group

    < 4.7 kg Lilliput 1 350 6 34.7 12.0 kg Lilliput 2 550 21 2112.0 20.0 kg EOS I 750 7 6

    20.0 35.0 kg EOS II 850 4 5

    (CPB circuit: Dideco Inc, Mirandola, Italy)

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    .

    Children stratified accordin to wei ht and the resenceor the absence of a cyanotic disease

    Transfusion tri er

    On-bypass: 20% hematocritPost-bypass: 24% hematocrit

    Additional fluids

    - 'ICU: 4% albumin

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    .

    Children stratified accordin to wei ht and the resenceor the absence of a cyanotic disease

    Transfusion tri er

    On-bypass: 20% hematocritPost-bypass: 24% hematocrit

    Additional fluids

    - 'ICU: 4% albumin

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    .

    4% albumin 6% HES 130/0.4

    Age (mo)[range]

    27,5 35,0[ 1,5 - 160 ]

    33,7 37,9[ 1 - 162 ]

    Preop weight (kg)[range]

    9,9 7,2[ 3,7 - 35,0 ]

    10,8 7,2[ 3,3 - 33,6 ]

    Preop RBC mass (ml) 292 231 322 225

    CPB time(min) 105 40 112 35

    Aortic clamp (min) 51 26 59 34

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    .

    120

    60

    80 40

    60

    20

    40 20

    0 0

    .

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    .

    Posto cristalloids ml/k Posto colloid ml/k

    80 40

    60 30

    40 20

    20 10

    0 0

    4% albumin 6% HES 130/0.4

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    .

    60

    120

    -

    40 80

    60

    20

    20

    40

    0 0

    .

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    .

    80

    80

    60 60

    40 40

    20 20

    0 0

    .

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    .

    120

    80

    20

    60

    20

    40

    00

    .

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    .

    120

    60

    80 40

    p

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    .

    Perop fluid in (ml/kg) Perop fluid out (ml/kg) Perop fluid balance (ml/kg)

    200 200

    60

    p

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    Albumin vs HES 130/0.4

    in Pediatric Cardiac Surgery

    Calculation of glomerular filtration rate (GFR) according to Schwartz GJ et al.

    Pediatrics 1976; 58:259-263

    From Hanart C et al. Eur J Anaesth abstract, 2009.

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    .

    4% albumin 6% HES 130/0.4

    ICU LOS (d)[range]

    5,7 5,4[ 2 - 34 ]

    6,8 6,1[ 2 - 28 ]

    Hospital LOS (d)[range]

    15,6 11,4[ 2 - 68 ]

    16,3 9,4[ 6 - 52 ]

    Postop weight (kg)[range]

    9,9 7,0 10,8 7,0

    Wei ht difference k - 0 03 0 91 -0 06 1 08

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    Albumin vs HES 130/0.4

    n e atr c ar ac urgery

    Limitations of the study Effects on long term outcome ?

    -

    Not a pure double-blind comparison

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    Colloids in Pediatric Cardiac Surgery:

    e uture

    HES 130/0.4 versus 5 % albumin Prospective randomized double-blind study (N=60)

    Safety analysis up to 30-day postop

    Saline versus balanced HES 130/0.4 Prospective randomized double-blind study

    First objective: calculated blood loss

    Secondary objectives: renal function, inflammatory response

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    HES 130/0.4 in Pediatric Surgery Patients:

    onc us ons

    HES 130/0.4 may represent an interesting alternative

    to albumin in children undergoing surgery, in particular

    profile of this 3rd generation of HES

    Next step: to evaluate the potential benefit of a

    balanced fluid replacement strategy

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    Thank You For Your Attention

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    Colloids: Natural Vs. Synthetics

    4-5% 3-4%

    6%

    Volemic ex ansionimmediate (%)

    duration (h)

    100

    4

    70 - 90

    2 - 3

    100-120

    4

    allergyhemostasis

    +

    ++

    rena unc on

    Max daily dose (ml/kg) no no 50

    Price (Euros) 40 4 9-12