A pilot study of a trial of tight control of blood pressure during hip fracture surgery in older people

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN89812075
• Date of registration: 30/08/2016
• Prospective Registration: Yes
• Primary sponsor: University of Nottingham
• Public title: A pilot study of a trial of tight control of blood pressure during hip fracture surgery in older people
• Scientific title: Hip fracture intervention study for prevention of hypotension (HIP-HOP) trial: pilot study
• Date of first enrolment: 01/10/2016
• Target sample size: 75
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN89812075
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment, Drug, Complex Intervention, Surgery (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Iain Moppett

Key inclusion & exclusion criteria

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

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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh
Circulatory System
Hypertension

Intervention(s)

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.

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

30629

Source(s) of Monetary Support

National Institute of Academic Anaesthesia

Ethics review

Status:
Approval date:
Contact:

East Midlands - Nottingham 1 Research Ethics Committee, 13/04/2016, ref: 16/EM/0036

Results

• Results available: Yes
• Date Completed: 01/02/2019