Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jul 25;18(1):350.
doi: 10.1186/s13063-017-2066-5.

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Iain Keith Moppett  1 , Stuart White  2 , Richard Griffiths  3 , Donal Buggy  4
Affiliations
Randomized Controlled Trial

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Iain Keith Moppett et al. Trials. .

Abstract

Background: Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control.

Methods/design: We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence.

Discussion: This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study.

Trial registration: ISRCTN Registry identifier: ISRCTN89812075 . Registered on 30 August 2016.

Keywords: Acute kidney injury/aetiology; Arterial pressure; Hip fractures/surgery; Humans; Hypotension/complications; Hypotension/mortality; Intra-operative; Monitoring; Post-operative complications/aetiology.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The trial received favourable ethical approval from the National Research Ethics Service (NRES) Committee East Midlands – Nottingham 1 on 13 April 2016 (NRES reference 16/EM/0036). This approval applies to all the participating centres (Nottingham, Brighton and Peterborough). The trial sponsor is the University of Nottingham (reference 15086). Nottingham University Hospitals NHS Research & Innovation (R&I) approval was gained on 27 October 2016 (R&I reference 16AN002). The first patient was recruited on 22 December 2016.

Consent for publication

The capacity for providing consent is assessed routinely by the orthopaedic team, which decides whether the patient is competent to provide consent for the surgical procedure. If the orthopaedic team deems the patient unable to consent to surgery, then the patient will be deemed incapable of consenting to enter the study. A member of the research team also performs an additional check of the participant’s ability to provide consent immediately prior to starting the study. All members of the research team are trained in obtaining consent in accordance with guidance for good clinical practice [36]. An informed consent form will be collected from each participant before the patient undergoes any interventions (including physical examination and history taking) related to the study. One copy of this form will be kept by the participant, one will be kept by the investigator, and a third will be retained in the patient’s hospital records. Because the study will involve participants who may temporarily lose their capacity during the course of the study as a result of post-operative delirium or use of analgesia, data collection and blood tests will be carried out in accordance with regulation 30 of the Mental Capacity Act 2005 and Health Research Authority guidance [34, 37]. Due consideration to the current circumstances of the participant will be taken, and personal or nominated consultees (a senior member of the healthcare team [consultant or senior ward nurse]) will be consulted. Regardless, if participants with temporary loss of capacity appear to object (particularly related to blood tests), then these will not be taken at that time. Depending on the context, given the fluctuating nature of delirium, a further assessment may be made later that day or the next day.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Clinical Effectiveness Unit, Royal College of Physicians. Falls and Fragility Fracture Audit Programme national hip fracture database: Anaesthesia Sprint Audit of Practice 2014. London: Royal College of Physicians. 2014. http://www.nhfd.co.uk/20/hipfractureR.nsf/4e9601565a8ebbaa802579ea0035b2.... Accessed 14 July 2017.
    1. White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, et al. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2) Anaesthesia. 2016;71:506–14. doi: 10.1111/anae.13415. - DOI - PubMed
    1. Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, et al. Hospital stay and mortality are increased in patients having a “triple low” of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012;116:1195–203. doi: 10.1097/ALN.0b013e31825683dc. - DOI - PubMed
    1. White SM, Griffiths R, Moppett IK. Type of anaesthesia for hip fracture surgery - the problems of trial design. Anaesthesia. 2012;67:574–8. doi: 10.1111/j.1365-2044.2012.07120.x. - DOI - PubMed
    1. Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, et al. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012;116:658–64. doi: 10.1097/ALN.0b013e3182472320. - DOI - PubMed

Publication types

MeSH terms

Substances

Associated data