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The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial

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Harvard

Ekeloef, S, Homilius, M, Stilling, M, Ekeloef, P, Koyuncu, S, Münster, A-MB, Meyhoff, CS, Gundel, O, Holst-Knudsen, J, Mathiesen, O & Gögenur, I 2019, 'The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial' BMJ, bind 367, s. l6395. https://doi.org/10.1136/bmj.l6395

APA

Ekeloef, S., Homilius, M., Stilling, M., Ekeloef, P., Koyuncu, S., Münster, A-M. B., ... Gögenur, I. (2019). The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial. BMJ, 367, l6395. https://doi.org/10.1136/bmj.l6395

CBE

MLA

Vancouver

Author

Ekeloef, Sarah ; Homilius, Morten ; Stilling, Maiken ; Ekeloef, Peter ; Koyuncu, Seda ; Münster, Anna-Marie Bloch ; Meyhoff, Christian S ; Gundel, Ossian ; Holst-Knudsen, Julie ; Mathiesen, Ole ; Gögenur, Ismail. / The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial) : phase II randomised clinical trial. I: BMJ. 2019 ; Bind 367. s. l6395.

Bibtex

@article{902e0cd5f0bc4993b2fa8072cdd0df3b,
title = "The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial",
abstract = "OBJECTIVE: To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery.DESIGN: Phase II, multicentre, randomised, observer blinded, clinical trial.SETTING: Three Danish university hospitals, 2015-17.PARTICIPANTS: 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group).INTERVENTION: The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes.MAIN OUTCOME MEASURES: The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere.RESULTS: 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70{\%}) women). The primary outcome occurred in 25 of 168 (15{\%}) patients in the RIPC group and 45 of 158 (28{\%}) in the control group (odds ratio 0.44, 95{\%} confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20{\%}) in the RIPC group and 90 of 287 (31{\%}) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3{\%}) in the RIPC group and 21 patients (7{\%}) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit).CONCLUSIONS: RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality.TRIAL REGISTRATION: ClinicalTrials.gov NCT02344797.",
keywords = "Aged, Aged, 80 and over, Emergency Treatment, Female, Fracture Fixation/adverse effects, Heart Injuries/etiology, Hip Fractures/surgery, Humans, Intention to Treat Analysis, Ischemic Preconditioning, Myocardial/methods, Male, Myocardial Infarction/etiology, Postoperative Complications/etiology, Single-Blind Method, Time Factors, Treatment Outcome",
author = "Sarah Ekeloef and Morten Homilius and Maiken Stilling and Peter Ekeloef and Seda Koyuncu and M{\"u}nster, {Anna-Marie Bloch} and Meyhoff, {Christian S} and Ossian Gundel and Julie Holst-Knudsen and Ole Mathiesen and Ismail G{\"o}genur",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",
year = "2019",
month = "12",
day = "4",
doi = "10.1136/bmj.l6395",
language = "English",
volume = "367",
pages = "l6395",
journal = "BMJ",
issn = "1756-1833",
publisher = "B M J Group",

}

RIS

TY - JOUR

T1 - The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial)

T2 - phase II randomised clinical trial

AU - Ekeloef, Sarah

AU - Homilius, Morten

AU - Stilling, Maiken

AU - Ekeloef, Peter

AU - Koyuncu, Seda

AU - Münster, Anna-Marie Bloch

AU - Meyhoff, Christian S

AU - Gundel, Ossian

AU - Holst-Knudsen, Julie

AU - Mathiesen, Ole

AU - Gögenur, Ismail

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2019/12/4

Y1 - 2019/12/4

N2 - OBJECTIVE: To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery.DESIGN: Phase II, multicentre, randomised, observer blinded, clinical trial.SETTING: Three Danish university hospitals, 2015-17.PARTICIPANTS: 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group).INTERVENTION: The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes.MAIN OUTCOME MEASURES: The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere.RESULTS: 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70%) women). The primary outcome occurred in 25 of 168 (15%) patients in the RIPC group and 45 of 158 (28%) in the control group (odds ratio 0.44, 95% confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20%) in the RIPC group and 90 of 287 (31%) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3%) in the RIPC group and 21 patients (7%) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit).CONCLUSIONS: RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality.TRIAL REGISTRATION: ClinicalTrials.gov NCT02344797.

AB - OBJECTIVE: To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery.DESIGN: Phase II, multicentre, randomised, observer blinded, clinical trial.SETTING: Three Danish university hospitals, 2015-17.PARTICIPANTS: 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group).INTERVENTION: The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes.MAIN OUTCOME MEASURES: The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere.RESULTS: 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70%) women). The primary outcome occurred in 25 of 168 (15%) patients in the RIPC group and 45 of 158 (28%) in the control group (odds ratio 0.44, 95% confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20%) in the RIPC group and 90 of 287 (31%) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3%) in the RIPC group and 21 patients (7%) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit).CONCLUSIONS: RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality.TRIAL REGISTRATION: ClinicalTrials.gov NCT02344797.

KW - Aged

KW - Aged, 80 and over

KW - Emergency Treatment

KW - Female

KW - Fracture Fixation/adverse effects

KW - Heart Injuries/etiology

KW - Hip Fractures/surgery

KW - Humans

KW - Intention to Treat Analysis

KW - Ischemic Preconditioning, Myocardial/methods

KW - Male

KW - Myocardial Infarction/etiology

KW - Postoperative Complications/etiology

KW - Single-Blind Method

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1136/bmj.l6395

DO - 10.1136/bmj.l6395

M3 - Journal article

VL - 367

SP - l6395

JO - BMJ

JF - BMJ

SN - 1756-1833

ER -

ID: 58951468