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    Clinical Trial Results:
    Influence of albumin on the development of acute renal dysfunction associated with cardiac surgery under extracorporeal circulation

    Summary
    EudraCT number
    2017-003027-30
    Trial protocol
    ES  
    Global end of trial date
    20 Dec 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jun 2022
    First version publication date
    06 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IIBSP-ALB-2017-72
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recerca Hospital de la Santa Creu i Sant Pau
    Sponsor organisation address
    Carrer de Sant Quintí, 77, Barcelona, Spain, 08041
    Public contact
    UICEC Sant Pau, Institut de Recerca Hospital de la Santa Creu i Sant Pau, 34 935537636, uicec@santpau.cat
    Scientific contact
    UICEC Sant Pau, Institut de Recerca Hospital de la Santa Creu i Sant Pau, 34 935537636, uicec@santpau.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To analyze the effect of the use of human albumin during ECC on the incidence of ARD-ACC in patients undergoing cardiac surgery with CPB diagnosed according to the KDIGO scale during the first 7 days after the intervention.
    Protection of trial subjects
    The study will be conducted in strict accordance with international ethical recommendations for research and clinical trials in humans. Likewise, the standards contained in the Declaration of Helsinki will be guaranteed and will be developed in accordance with the protocol and with the standard work procedures (SOPs) that ensure compliance with the standards of Good Clinical Practice (PCB). The investigator should explain to the patient (when possible) or his authorized legal representative, the nature of the study, its purposes, procedures, estimated duration, the potential risks and benefits related to the participation in the study, as well as any inconvenience that this may cause. can suppose. Each of the participants should be warned that their participation in the study is voluntary and that they can leave the study at any time, without this affecting their subsequent treatment or their relationship with the professionals who treat them. For this, an information / consent sheet has been designed for the patient or the authorized legal representative, which is attached. Human albumin is currently used routinely in certain centers for priming the CEC circuit during cardiac surgery, its beneficial effect has been demonstrated in many respects, but its effect on renal function during the immediate postoperative period has not been evaluated. . The use of albumin in this context has shown benefits in terms of reducing postoperative bleeding, less need for fluid therapy, improved plasma oncotic pressure, as well as decreased formation of microthrombi, improved perfusion during circulation extracorporeal, decreased levels of nephrotoxic free radicals released during extracorporeal circulation and other effects that may be protective factors of kidney function during the period of extracorporeal circulation. Monitoring, audits, CEIC reviews and regulatory inspections related to the test will be allowed, facilitating direct access to the original documents / data.
    Background therapy
    Albumin in cardiac surgery Albumin is a 66 kD protein synthesized in the liver, which is responsible for 75 to 80% of plasma oncotic pressure, with a half-life of around 20 days [19], being of high importance for proper function of the vascular barrier and the integrity of the glycocalix, bases of vascular permeability and homeostasis of the intracellular and interstitial spaces, in which albumin is a fundamental regulator of the passage of liquids between compartments according to the current model. As a drug it is obtained from human plasma and is used in solution at different concentrations for clinical use, being widely used in medicine and in the environment of the patient undergoing cardiac surgery as fluid therapy for its plasma-expanding properties with maintenance of oncotic pressure , antioxidant effect and as a transporter of molecules such as hormones, iron, bilirubin, free fatty acids, drugs and other elements, having a wide spectrum of indications. Unlike other colloids such as hydroxyethyl starch, its use has been associated with few negative effects. Its use for priming the circuit of extracorporeal circulation during cardiac surgery has been commonly used, first of all for the ability to form a layer on the surface of the circuit, protecting blood from direct contact with its surface. It can cause protein denaturation, activation of the complement cascade, release of inflammatory mediators, and platelet activation. Secondly, the use of albumin in circuit priming can attenuate the drop in oncotic pressure due to a dilutional effect during the ECC period, an effect that can cause edema in the different organs with consequent dysfunction. In a meta-analysis of the use of albumin in the priming of the CEC carried out in 2004, it was concluded that the priming with albumin preserved the platelet count better than the priming of the CEC with crystalloids, conserved the oncotic pressure better, favorably influenced fluid balance (less fluid requirement
    Evidence for comparator
    Given the growing evidence that the use of albumin can decrease the incidence of acute kidney injury in patients with hypoalbuminemia who underwent cardiac surgery without ECC, that the majority of patients present hypoalbuminemia after ECC, together with the fact that the high incidence of ARD during the immediate postoperative period and to the widely studied properties of albumin, our interest is to investigate the use of albumin for patients undergoing cardiac surgery with ECC, using it for purging the circuit, since this period supposes, as described above, a kidney injury perfectly delimited in time and clearly associated with a significant incidence of acute kidney injury, due to injury mechanisms that could be partially cushioned by the use of albumin, as a consequence of its properties. This study aims to obtain information about the effect that albumin can have in this population of patients with a high incidence of acute kidney dysfunction, and if this benefit exists, to know whether or not it is significant to justify its systematic use. Among the reasons that make this project potentially relevant from a scientific point of view, there is mainly the paucity of studies of this type that may allow establishing the recommendation for the use of albumin to reduce the incidence of ACC-DRA. Therefore, a great scientific impact of the results is expected. From the health point of view, the results can have a high socio-economic impact, since the costs associated with the management of ARD are high, so an improvement in the cost-effectiveness ratio through the use of albumin can produce significant savings in the SNS. We consider that this project will constitute a tool that will provide quality evidence, and its results could not only be the reason for publication in scientific journals, but also be included in clinical practice guidelines as a recommendation that allows optimizing the prognosis of patients who require undergoing cardiac surgery with ECC.
    Actual start date of recruitment
    02 Nov 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 248
    Worldwide total number of subjects
    248
    EEA total number of subjects
    248
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    91
    From 65 to 84 years
    152
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    The population consists of patients who underwent cardiac surgery scheduled under ECC. Recruitment will take place at the pre-anesthetic visit.

    Pre-assignment
    Screening details
    Inclusion criteria: Adult patients (> 18 years) scheduled for cardiac surgery by ECC, who present GFR greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40%. Exclu

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Blinding will not be necessary since the primed preparation of the CEC circuit will be performed by the infusion nursing team, and the solution with the experimental drug (albumin) looks the same as the solution without it.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Plasmalyte
    Arm description
    Control treatment: Plasmalyte serum used for priming the extracorporeal circulation circuit.
    Arm type
    Active comparator

    Investigational medicinal product name
    Plasmalyte
    Investigational medicinal product code
    B05BB01
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Extracorporeal use
    Dosage and administration details
    used during purged of CEC

    Arm title
    Albumin
    Arm description
    Experimental treatment : Human Albumin for the priming of the CEC circuit , added to the usual solution (plasma serum ) in sufficient quantity to achieve a concentration of 4% of the total priming volume versus usual priming with serum . plasmalyte . Human albumin is already currently used for priming the CEC on certain occasions and in hospital centers.
    Arm type
    Active comparator

    Investigational medicinal product name
    Albumin
    Investigational medicinal product code
    B05A1
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Extracorporeal use
    Dosage and administration details
    Albumin 4% used during purged of CEC

    Number of subjects in period 1
    Plasmalyte Albumin
    Started
    122
    126
    Completed
    122
    126

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Plasmalyte
    Reporting group description
    Control treatment: Plasmalyte serum used for priming the extracorporeal circulation circuit.

    Reporting group title
    Albumin
    Reporting group description
    Experimental treatment : Human Albumin for the priming of the CEC circuit , added to the usual solution (plasma serum ) in sufficient quantity to achieve a concentration of 4% of the total priming volume versus usual priming with serum . plasmalyte . Human albumin is already currently used for priming the CEC on certain occasions and in hospital centers.

    Reporting group values
    Plasmalyte Albumin Total
    Number of subjects
    122 126 248
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    45 46 91
        From 65-84 years
    75 77 152
        85 years and over
    2 3 5
    Age continuous
    Units: years
        geometric mean (standard deviation)
    65.836 ( 12.9826 ) 67.71 ( 12.76 ) -
    Gender categorical
    Units: Subjects
        Female
    79 83 162
        Male
    43 43 86
    Creatinine
    Units: micromole(s)/litre
        geometric mean (standard deviation)
    78.42 ( 11.89 ) 81.76 ( 14.20 ) -
    GFR
    Units: mL/min/1.73m2
        geometric mean (standard deviation)
    80.48 ( 16.21 ) 76.09 ( 16.13 ) -
    Albumin
    Units: gram(s)/litre
        geometric mean (standard deviation)
    40.774 ( 4.3416 ) 41.083 ( 3.5112 ) -

    End points

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    End points reporting groups
    Reporting group title
    Plasmalyte
    Reporting group description
    Control treatment: Plasmalyte serum used for priming the extracorporeal circulation circuit.

    Reporting group title
    Albumin
    Reporting group description
    Experimental treatment : Human Albumin for the priming of the CEC circuit , added to the usual solution (plasma serum ) in sufficient quantity to achieve a concentration of 4% of the total priming volume versus usual priming with serum . plasmalyte . Human albumin is already currently used for priming the CEC on certain occasions and in hospital centers.

    Primary: AKI

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    End point title
    AKI
    End point description
    End point type
    Primary
    End point timeframe
    5 days
    End point values
    Plasmalyte Albumin
    Number of subjects analysed
    122
    126
    Units: Percentage
        AKI
    38
    37
        non AKI
    84
    89
    Statistical analysis title
    Comparation
    Comparison groups
    Plasmalyte v Albumin
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    ≥ 0.05
    Method
    Chi-squared
    Parameter type
    Odds ratio (OR)
    Confidence interval
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 year
    Adverse event reporting additional description
    All adverse events that occur will be collected and their causal relationship with the treatment received, severity and condition of unexpected will be evaluated.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Plasmalyte
    Reporting group description
    Barcelona is not routinely applied to purge the CEC, it is carried out with crystalloid solution (plasmalyte serum), using albumin in CEC in certain exceptional circumstances (severe hypoproteinemia associated with anasarca, etc.) Control treatment: Plasmalyte serum used for priming the extracorporeal circulation circuit.

    Reporting group title
    Albumin
    Reporting group description
    Experimental treatment : Human Albumin for the priming of the CEC circuit , added to the usual solution (plasma serum ) in sufficient quantity to achieve a concentration of 4% of the total priming volume versus usual priming with serum . plasmalyte . Human albumin is already currently used for priming the CEC on certain occasions and in hospital centers.

    Serious adverse events
    Plasmalyte Albumin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 122 (2.46%)
    2 / 126 (1.59%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    0
    2
    Blood and lymphatic system disorders
    Death
    Additional description: Massive bleeding
         subjects affected / exposed
    3 / 122 (2.46%)
    2 / 126 (1.59%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Plasmalyte Albumin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 122 (11.48%)
    14 / 126 (11.11%)
    Vascular disorders
    Shock
         subjects affected / exposed
    9 / 122 (7.38%)
    8 / 126 (6.35%)
         occurrences all number
    9
    8
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    5 / 122 (4.10%)
    5 / 126 (3.97%)
         occurrences all number
    5
    5
    Blood and lymphatic system disorders
    Bleeding time normal
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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