Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Compliance to the intervention
研究概览
简要总结
Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture.
Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up.
Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up.
Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.
详细描述
This is a single centre, single arm feasibility study. The team will aim to recruit 12 participants to complete a programme of RIC for up to 2 weeks following hip fracture or until discharge from hospital or rehabilitation centre.
It is not known whether the main potential protective events resulting from RIC occur due to the short-term effects (likely changes in vascular sensitivity, blood flow etc) or the longer-term effects (modulation of inflammation etc that occur through changes in gene expression). However, the team have chosen a dosing strategy that they feel is practical to deliver given the average length of time people spend in hospital after hip fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged > 18 years)
- •Participant has had a hip fracture identified on X-ray or computed tomography (CT) scan.
- •Qualifying hip fracture has not occurred more than 7 days prior to enrollment.
- •Able to give written informed consent.
- •In the opinion of the treating physician would be able to conform to the study protocol and procedures.
排除标准
- •History or presence of significant peripheral vascular disease in the limb conditioned.
- •History or presence of complex neuropathic pains or peripheral neuropathy in the limb conditioned.
- •Presence of lymphoedema in the limb conditioned.
- •Presence of skin ulceration to the limb conditioned.
- •Uncontrolled arrhythmia, hypertension, diabetes or angina.
- •Third degree heart block or progressive heart failure.
- •Acute aortic dissection, myocarditis, or pericarditis.
- •Acute deep vein thrombosis, pulmonary embolism.
- •Suspected or known dissecting aneurysm.
- •Stroke or TIA myocardial infarction in the last 4 weeks.
研究组 & 干预措施
RIC Interventional Arm
Participants recruited to this arm will receive a programme of Remote Ischaemic Conditioning for up to 2 weeks following hip fracture, or discharge from hospital or rehabilitation centre.
干预措施: Remote Ischaemic Conditioning (Procedure)
结局指标
主要结局
Compliance to the intervention
时间窗: From enrolment to end of treatment at 2 weeks
This outcome measure will be assessed using the patient monitoring diaries. Compliance will be defined as; ● More than 80% of intended RIC cycles completed
Safety of RIC in patients who have suffered hip fracture
时间窗: From enrolment to the end of follow up at 3 months
This outcome measure will be assessed by review of their clinical data at baseline and daily intervention visits, review of the side effects during the intervention period and reporting of any AE's throughout the study period. Safety will be defined as; * No reported SAE's directly related to RIC * Unexpected adverse events in less than 1/3 participants
Participant acceptability - Symptom severity scores
时间窗: From enrolment to end of follow up at 3 months
This outcome measure will be assessed by review of side effects / adverse events reported to researchers throughout the intervention period. Acceptability will be defined as; ● Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms (based on Likert Scale 1-5; 1 representing no issues; 5 representing severe symptoms)
Participant acceptability - Semi-structured interviews
时间窗: From enrolment to end of follow up at 3 months
This outcome measure will be reviewed through the qualitative interviews undertaken in a subset of participants. Acceptability will be defined as; ● Reports from semi-structured interviews
Study feasibility
时间窗: From enrolment to end of follow up at 3 months
This outcome measure will be assessed by review of patient recruitment, completeness of outcome measure assessments recorded and number of follow up assessments completed. Feasibility will be defined as; * Four patients recruited within the first 2 months of recruitment * \>80% of outcome measure assessments recorded and follow up assessments completed.
次要结局
- Clinical Outcomes - Inpatient Mortality(From enrolment to end of follow up at 3 months)
- Clinical Outcomes - Inpatient Length of Stay(From enrolment to end of follow up at 3 months)
- Clinical Outcomes - Rate of inpatient complications(From enrolment to end of follow up at 3 months)
- Clinical Outcomes - Blood pressure(From enrolment to end of follow up at 3 months)
- Clinical Outcomes - Function at discharge(From enrolment to end of follow up at 3 months)
- Clinical Outcomes - Discharge destination(From enrolment to end of follow up at 3 months)
- Mechanisms of action(From enrolment to end of treatment at 2 weeks)