Validation and Clinical Evaluation of a Method for Double-Blinded Blood Pressure Target Investigation in Intensive Care Medicine

Johannes Grand, Anna Sina P. Meyer, Christian Hassager, Henrik Schmidt, Jacob E. Moller, Jesper Kjaergaard

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVES: No double-blinded clinical trials have investigated optimal mean arterial pressure targets in the ICU. The aim of this study was to develop and validate a method for blinded investigation of mean arterial pressure targets in patients monitored with arterial catheter in the ICU.

DESIGN: Prospective observational study (substudy A) and prospective, randomized, controlled clinical study (substudy B).

SETTING: ICU, Department of Cardiology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.

PATIENTS: Adult patients resuscitated from out-of-hospital cardiac arrest.

INTERVENTIONS: Standard blood pressure measuring modules were offset to display 10% lower or higher blood pressure values. We then: 1) confirmed this modification in vivo by comparing offset to standard modules in 22 patients admitted to the ICU. Thereafter we 2) verified the method in two randomized, clinical trials, each including 50 out-of-hospital cardiac arrest patients, where the offset of the blood pressure module was blinded to the treating staff.

MEASUREMENTS AND MAIN RESULTS: Substudy A showed that the expected separation of blood pressure measurements was achieved with an excellent correlation of the offset and standard modules (R = 0.997). Bland-Altman plots showed no bias of modified modules over a clinically relevant range of mean arterial pressure. The primary endpoint of the clinical trials was between-group difference of norepinephrine dose needed to achieve target mean arterial pressure. Trial 1 aimed at a 10% difference between groups in mean arterial pressure (targets: 65 and 72 mm Hg, respectively) and demonstrated a separation of 5 ± 1 mm Hg (p < 0.001). The difference in norepinephrine dose was not significantly different (0.03 ± 0.03 µg/kg/min; p = 0.42). Trial 2 aimed at a 20% difference between groups in mean arterial pressure (targets: 63 and 77 mm Hg, respectively). Separation was 12 ± 1 mm Hg (p < 0.01) in mean arterial pressure and 0.07 ± 0.03 µg/kg/min (p < 0.01) in norepinephrine dose.

CONCLUSIONS: The present method is feasible and robust and provides a platform for double-blinded comparison of mean arterial pressure targets in critically ill patients.

OriginalsprogEngelsk
TidsskriftCritical Care Medicine
Vol/bind46
Udgave nummer10
Sider (fra-til)1626-1633
ISSN0090-3493
DOI
StatusUdgivet - okt. 2018

Fingeraftryk

Arterial Pressure
Medicine
Clinical Trials
Denmark
Critical Illness
Catheters
Randomized Controlled Trials

Citer dette

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title = "Validation and Clinical Evaluation of a Method for Double-Blinded Blood Pressure Target Investigation in Intensive Care Medicine",
abstract = "OBJECTIVES: No double-blinded clinical trials have investigated optimal mean arterial pressure targets in the ICU. The aim of this study was to develop and validate a method for blinded investigation of mean arterial pressure targets in patients monitored with arterial catheter in the ICU.DESIGN: Prospective observational study (substudy A) and prospective, randomized, controlled clinical study (substudy B).SETTING: ICU, Department of Cardiology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.PATIENTS: Adult patients resuscitated from out-of-hospital cardiac arrest.INTERVENTIONS: Standard blood pressure measuring modules were offset to display 10{\%} lower or higher blood pressure values. We then: 1) confirmed this modification in vivo by comparing offset to standard modules in 22 patients admitted to the ICU. Thereafter we 2) verified the method in two randomized, clinical trials, each including 50 out-of-hospital cardiac arrest patients, where the offset of the blood pressure module was blinded to the treating staff.MEASUREMENTS AND MAIN RESULTS: Substudy A showed that the expected separation of blood pressure measurements was achieved with an excellent correlation of the offset and standard modules (R = 0.997). Bland-Altman plots showed no bias of modified modules over a clinically relevant range of mean arterial pressure. The primary endpoint of the clinical trials was between-group difference of norepinephrine dose needed to achieve target mean arterial pressure. Trial 1 aimed at a 10{\%} difference between groups in mean arterial pressure (targets: 65 and 72 mm Hg, respectively) and demonstrated a separation of 5 ± 1 mm Hg (p < 0.001). The difference in norepinephrine dose was not significantly different (0.03 ± 0.03 µg/kg/min; p = 0.42). Trial 2 aimed at a 20{\%} difference between groups in mean arterial pressure (targets: 63 and 77 mm Hg, respectively). Separation was 12 ± 1 mm Hg (p < 0.01) in mean arterial pressure and 0.07 ± 0.03 µg/kg/min (p < 0.01) in norepinephrine dose.CONCLUSIONS: The present method is feasible and robust and provides a platform for double-blinded comparison of mean arterial pressure targets in critically ill patients.",
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author = "Johannes Grand and Meyer, {Anna Sina P.} and Christian Hassager and Henrik Schmidt and Moller, {Jacob E.} and Jesper Kjaergaard",
year = "2018",
month = "10",
doi = "10.1097/CCM.0000000000003289",
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Validation and Clinical Evaluation of a Method for Double-Blinded Blood Pressure Target Investigation in Intensive Care Medicine. / Grand, Johannes; Meyer, Anna Sina P.; Hassager, Christian; Schmidt, Henrik; Moller, Jacob E.; Kjaergaard, Jesper.

I: Critical Care Medicine, Bind 46, Nr. 10, 10.2018, s. 1626-1633.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Validation and Clinical Evaluation of a Method for Double-Blinded Blood Pressure Target Investigation in Intensive Care Medicine

AU - Grand, Johannes

AU - Meyer, Anna Sina P.

AU - Hassager, Christian

AU - Schmidt, Henrik

AU - Moller, Jacob E.

AU - Kjaergaard, Jesper

PY - 2018/10

Y1 - 2018/10

N2 - OBJECTIVES: No double-blinded clinical trials have investigated optimal mean arterial pressure targets in the ICU. The aim of this study was to develop and validate a method for blinded investigation of mean arterial pressure targets in patients monitored with arterial catheter in the ICU.DESIGN: Prospective observational study (substudy A) and prospective, randomized, controlled clinical study (substudy B).SETTING: ICU, Department of Cardiology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.PATIENTS: Adult patients resuscitated from out-of-hospital cardiac arrest.INTERVENTIONS: Standard blood pressure measuring modules were offset to display 10% lower or higher blood pressure values. We then: 1) confirmed this modification in vivo by comparing offset to standard modules in 22 patients admitted to the ICU. Thereafter we 2) verified the method in two randomized, clinical trials, each including 50 out-of-hospital cardiac arrest patients, where the offset of the blood pressure module was blinded to the treating staff.MEASUREMENTS AND MAIN RESULTS: Substudy A showed that the expected separation of blood pressure measurements was achieved with an excellent correlation of the offset and standard modules (R = 0.997). Bland-Altman plots showed no bias of modified modules over a clinically relevant range of mean arterial pressure. The primary endpoint of the clinical trials was between-group difference of norepinephrine dose needed to achieve target mean arterial pressure. Trial 1 aimed at a 10% difference between groups in mean arterial pressure (targets: 65 and 72 mm Hg, respectively) and demonstrated a separation of 5 ± 1 mm Hg (p < 0.001). The difference in norepinephrine dose was not significantly different (0.03 ± 0.03 µg/kg/min; p = 0.42). Trial 2 aimed at a 20% difference between groups in mean arterial pressure (targets: 63 and 77 mm Hg, respectively). Separation was 12 ± 1 mm Hg (p < 0.01) in mean arterial pressure and 0.07 ± 0.03 µg/kg/min (p < 0.01) in norepinephrine dose.CONCLUSIONS: The present method is feasible and robust and provides a platform for double-blinded comparison of mean arterial pressure targets in critically ill patients.

AB - OBJECTIVES: No double-blinded clinical trials have investigated optimal mean arterial pressure targets in the ICU. The aim of this study was to develop and validate a method for blinded investigation of mean arterial pressure targets in patients monitored with arterial catheter in the ICU.DESIGN: Prospective observational study (substudy A) and prospective, randomized, controlled clinical study (substudy B).SETTING: ICU, Department of Cardiology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.PATIENTS: Adult patients resuscitated from out-of-hospital cardiac arrest.INTERVENTIONS: Standard blood pressure measuring modules were offset to display 10% lower or higher blood pressure values. We then: 1) confirmed this modification in vivo by comparing offset to standard modules in 22 patients admitted to the ICU. Thereafter we 2) verified the method in two randomized, clinical trials, each including 50 out-of-hospital cardiac arrest patients, where the offset of the blood pressure module was blinded to the treating staff.MEASUREMENTS AND MAIN RESULTS: Substudy A showed that the expected separation of blood pressure measurements was achieved with an excellent correlation of the offset and standard modules (R = 0.997). Bland-Altman plots showed no bias of modified modules over a clinically relevant range of mean arterial pressure. The primary endpoint of the clinical trials was between-group difference of norepinephrine dose needed to achieve target mean arterial pressure. Trial 1 aimed at a 10% difference between groups in mean arterial pressure (targets: 65 and 72 mm Hg, respectively) and demonstrated a separation of 5 ± 1 mm Hg (p < 0.001). The difference in norepinephrine dose was not significantly different (0.03 ± 0.03 µg/kg/min; p = 0.42). Trial 2 aimed at a 20% difference between groups in mean arterial pressure (targets: 63 and 77 mm Hg, respectively). Separation was 12 ± 1 mm Hg (p < 0.01) in mean arterial pressure and 0.07 ± 0.03 µg/kg/min (p < 0.01) in norepinephrine dose.CONCLUSIONS: The present method is feasible and robust and provides a platform for double-blinded comparison of mean arterial pressure targets in critically ill patients.

KW - blood pressure

KW - critical care

KW - double-blind method

KW - hemodynamic monitoring

KW - out-of-hospital cardiac arrest

KW - septic

KW - shock

KW - Shock

KW - Hemodynamic monitoring

KW - Critical care

KW - Double-blind method

KW - Septic

KW - Out-of-hospital cardiac arrest

KW - Blood pressure

U2 - 10.1097/CCM.0000000000003289

DO - 10.1097/CCM.0000000000003289

M3 - Journal article

C2 - 29994882

VL - 46

SP - 1626

EP - 1633

JO - Critical Care Medicine

JF - Critical Care Medicine

SN - 0090-3493

IS - 10

ER -