A pilot study of a trial of tight control of blood pressure during hip fracture surgery in older people
| ISRCTN | ISRCTN89812075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89812075 |
| Secondary identifying numbers | 30629 |
- Submission date
- 30/08/2016
- Registration date
- 30/08/2016
- Last edited
- 14/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Around 70,000 mainly elderly people will have a hip fracture every year in the UK. It has a significant impact on the individual, families, carers and the health service. Recent studies have shown that there is a link between low blood pressure during surgery and worse outcomes afterwards. It is currently not known whether the low blood pressure is the cause of the problems or simply a sign of patients who become unwell following surgery. The study team hopes to undertake a large trial of tight control of blood pressure to see whether it makes a difference to major complications after surgery such as heart attack, stroke, confusion and kidney injury. Before this however, it is important to undertake a small study to find out if a large trial would be feasible. The aim of this study is to find out whether it is feasible to conduct a study looking at whether controlling blood pressure within tight limits during hip fracture surgery lead to fewer major complications (heart, brain and kidney individually) in the first week after surgery.
Who can participate?
Patients aged 70 and over who have a broken hip that requires surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. Both groups of patients receive standard surgical care, anaesthesia (being put to sleep for surgery) and after-surgery care. Those in the first group receive drugs and intravenous (through a drip) fluids to keep their blood pressure within quite tight limits during their surgery. Those in the second group receive standard care (which involves receiving drugs and fluids according to the clinical opinion of the doctors looking after them in surgery). Over the following seven days, participants in both groups receive daily blood tests to find out if they are showing signs of heart or kidney damage and are assessed for signs of confusion (brain damage). One month later, participants receive a follow up phone call to check on health status and where they are living. Survival is also followed up at these times and then one year later through reviewing medical records.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Queen’s Medical Centre (lead centre), Royal Sussex County Hospital and Peterborough City Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2015 to February 2019
Who is funding the study?
National Institute of Academic Anaesthesia (UK)
Who is the main contact?
Dr Iain Moppett
iain.moppett@nottingham.ac.uk
Contact information
Scientific
Anaesthesia and Critical Care
Division of Clinical Neuroscience
Queen’s Medical Centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0003-3750-6067 |
|---|---|
| Phone | +44 (0)115 823 0959 |
| iain.moppett@nottingham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Drug, Complex Intervention, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Hip fracture intervention study for prevention of hypotension (HIP-HOP) trial: pilot study |
| Study acronym | HIP-HOP |
| Study hypothesis | The aim of this study is to investigate the feasibility of recruiting participants to a study looking at whether reducing the amount of hypotension (number, severity and duration of episodes) during anaesthesia for hip fracture surgery decreases the frequency of delirium, heart abnormalities and kidney failure within five days after the operation. |
| Ethics approval(s) | East Midlands - Nottingham 1 Research Ethics Committee, 13/04/2016, ref: 16/EM/0036 |
| Condition | Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh |
| Intervention | Participants are randomised to one of two groups in blocks of unequal size, stratified by intended mode of anaesthesia and Nottingham Hip Fracture Score (≤4 vs >4). Participants in both groups will undergo hip fracture surgery and rehabilitation in accordance with national and local standards of care. Intervention group: Participants will receive active treatment as required to maintain both of the following: 1. SAP > 80% of baseline preoperative value 2. MAP > 75 mm Hg throughout The order and doses of treatments to achieve this will depend upon the clinical scenario but will include: 1. Fluid bolus to ensure adequate intravascular volume (associated with reduced requirement for vasoactive drugs11) 2. Combined beta / alpha-1 adrenergic agonist (ephedrine) 3. More selective alpha-1 adrenergic agonist (metaraminol) Blood pressure will be measured using standard non-invasive equipment every 2.5 minutes, or continuous non-invasive blood pressure monitoring (Nexfin, CNAP) throughout. Control group: Participants receive standard blood pressure control, which involves the administration of fluids and vasopressor drugs deemed clinically appropriate by the attending anaesthetist during surgery. Frequency of blood pressure monitoring will be at the attending anaesthetist’s discretion, but at least every 5 minutes. Study participants will be participating in the study for seven days whilst in hospital with a telephone follow-up at 30 days. Mortality at one year will be retrieved from central records. |
| Intervention type | Other |
| Primary outcome measure | Composite of presence or absence of defined cardiovascular, renal and delirium morbidity is measured daily for 7 days post-surgery using blood testing, clinical observations, and medical record review. |
| Secondary outcome measures | Clinical outcomes: 1. Presence or absence of each of defined cardiovascular, renal and delirium morbidity is measured daily for 7 days post-surgery using blood testing, clinical observations, and medical record review 2. Prevalence bone cement implantation syndrome will be measured using the Donaldson grading tool recorded during anaesthesia and surgery 3. Postoperative mortality is measured 5 and 30 days, and 1 year through medical record review 4. Quality of life is measured using the EQ-5D questionnaire 30 days post-surgery Feasibility outcomes: 1. Recruitment rate is recorded as the number of eligible participant who consent to participate in the study by 12 months 2. Protocol efficacy will be measured by recording arterial blood pressure intraoperatively and determining 2.1. The lowest arterial blood pressure (systolic, mean and diastolic) value following induction of anaesthesia; and 2.2. Time below threshold values (Mean arterial pressure 75mmHg, 80% pre-op mean arterial pressure) |
| Overall study start date | 19/01/2015 |
| Overall study end date | 01/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 75; UK Sample Size: 75. Final Sample Size: 75. |
| Participant inclusion criteria | 1. Aged over 70 years 2. Unilateral hip fracture requiring hemiarthroplasty, dynamic hip screw, proximal femoral nail fixation 3. Able to provide consent for trial participation |
| Participant exclusion criteria | 1. Patients due to undergo total hip arthroplasty 2. Patients with peri-prosthetic fractures 3. Patients without capacity 4. Pre-operative elevated troponin (measured for clinical reasons) |
| Recruitment start date | 01/10/2016 |
| Recruitment end date | 01/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Derby Road
Nottingham
NG7 2UH
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Peterborough and Stamford Hospitals NHS Trust
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Graduate Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed scientific journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/07/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/01/2019: The following changes have been made:
1. The intention to publish date has been changed from 31/07/2018 to 01/06/2019.
2. The final enrolment number has been added.
27/07/2017: Publication reference added.
