World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 28 August 2017
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: Ongoing
URL:  http://isrctn.com/ISRCTN89812075
Study type:  Interventional
Study design:  Randomised; Interventional; Design type: Treatment, Drug, Complex Intervention, Surgery (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Iain  Moppett
Address:  Anaesthesia and Critical Care Division of Clinical Neuroscience Queen’s Medical Centre University of Nottingham NG7 2UH Nottingham United Kingdom
Telephone: +44 (0)115 823 0959
Email: iain.moppett@nottingham.ac.uk
Affiliation: 
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
Secondary Sponsor(s)
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history