Journal Article

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

White, Stuart, Buggy, Donal, Moppett, Iain Keith, Griffiths, Richard

2017

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Aged / Anesthetics / Anti-inflammatory agents / Arterial Pressure - drug effects / Biomedicine / Blood pressure / Care and treatment / Clinical Protocols / Consent / Delirium / Diagnosis / Dosage and administration / Double-Blind Method / Emergency medical care / Feasibility Studies / Female / Fracture Fixation, Internal - adverse effects / Fracture Fixation, Internal - methods / Fracture Fixation, Internal - mortality / Fractures / General anesthesia / Health aspects / Health Sciences / Hemoglobin / Hip fracture repair / Hip fractures / Hip Fractures - diagnostic imaging / Hip Fractures - mortality / Hip Fractures - physiopathology / Hip Fractures - surgery / Hospitals / Humans / Hypotension / Hypotension - etiology / Hypotension - mortality / Hypotension - physiopathology / Hypotension - prevention & control / Hypotension/complications / Intra-operative / Kidneys / Male / Medicine / Medicine & Public Health / Monitoring / Monitoring, Intraoperative - methods / Mortality / Older people / Orthopedics / Participation / Patients / Pilot Projects / Post-operative complications/aetiology / Prospective Studies / Research Design / Risk Factors / Statistics for Life Sciences / Study Protocol / Surgery / Time Factors / Trauma / Treatment Outcome / United Kingdom / Vasoconstrictor Agents - administration & dosage / Vasoconstrictor Agents - adverse effects