Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

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Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

BMJ Open ◽

10.1136/bmjopen-2018-028537 ◽

2019 ◽

Vol 9 (4) ◽

pp. e028537 ◽

Cited By ~ 4

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ameen Patel ◽

Victoria Avram ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Perioperative Complications ◽

Public Awareness ◽

Controlled Trial ◽

Early Surgery ◽

All Cause Mortality ◽

Randomised Controlled

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.

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Comparison of two delayed strategies for renal replacement therapy initiation for severe acute kidney injury (AKIKI 2): a multicentre, open-label, randomised, controlled trial

The Lancet ◽

10.1016/s0140-6736(21)00350-0 ◽

2021 ◽

Vol 397 (10281) ◽

pp. 1293-1300 ◽

Cited By ~ 1

Author(s):

Stéphane Gaudry ◽

David Hajage ◽

Laurent Martin-Lefevre ◽

Saïd Lebbah ◽

Guillaume Louis ◽

...

Keyword(s):

Acute Kidney Injury ◽

Renal Replacement Therapy ◽

Randomised Controlled Trial ◽

Replacement Therapy ◽

Controlled Trial ◽

Kidney Injury ◽

Open Label ◽

Therapy Initiation ◽

Renal Replacement Therapy Initiation ◽

Randomised Controlled

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Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial

The Lancet ◽

10.1016/s0140-6736(20)30058-1 ◽

2020 ◽

Vol 395 (10225) ◽

pp. 698-708 ◽

Cited By ~ 34

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfan ◽

Ameen Patel ◽

Alben Sigamani ◽

...

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Randomised Controlled

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Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden

BMJ Open ◽

10.1136/bmjopen-2020-048337 ◽

2021 ◽

Vol 11 (12) ◽

pp. e048337

Author(s):

Joakim Dillner ◽

Johan Ursing

Keyword(s):

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Ethical Review ◽

Block Randomisation ◽

Ethical Approval ◽

Registration Number ◽

Secondary Endpoints ◽

Randomised Controlled ◽

Antibody Levels

IntroductionAlthough there are many studies on the use of convalescent plasma (CP) for treatment of COVID-19, it is not clear (1) which groups of patients may benefit, (2) what dose of plasma to give, or (3) which antibody levels the plasma should contain. Previous phase I/II studies and literature review suggest that CP should only be given to patients with viraemia, that a daily infusion should be given until the patient becomes virus free and that the neutralising antibody titre should preferably be >1:640Methods and analysisAn open randomised controlled trial enrolling patients with COVID-19, who must be SARS-CoV-2 positive in both airway and blood samples and admitted to a study hospital. Block randomisation 2:1 is to either 200 mL CP (preferably titre ≥1/640) daily for up to 10 days (until virus negative in blood) plus standard care or standard care only (control arm). The primary endpoint is mortality by day 28 after study inclusion. Secondary endpoints include mortality by day 60 and doses of plasma needed to clear viraemia. Assuming a reduced mortality of approximately 30% by the CP therapy and 85%–88% survival in the control arm, approximately 600 participants will be enrolled to the CP therapy arm and 300 participants to the control arm.Ethics and disseminationEthical approval has been granted by the Swedish Ethical Review Authority (reference: 2020-06277). Results from this trial will be compiled in a clinical study report, disseminated via journal articles and communicated to stakeholders.Trial registration numberNCT04649879.

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