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
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 populat...
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BioMed Central
2017
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| Online Access: | https://eprints.nottingham.ac.uk/48090/ |
| _version_ | 1848797689079136256 |
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| author | Moppett, Iain K. White, Stuart Griffiths, Richard Buggy, Donal |
| author_facet | Moppett, Iain K. White, Stuart Griffiths, Richard Buggy, Donal |
| author_sort | Moppett, Iain K. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:07:52Z |
| format | Article |
| id | nottingham-48090 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:07:52Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-480902020-05-04T18:56:40Z https://eprints.nottingham.ac.uk/48090/ 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 Moppett, Iain K. White, Stuart Griffiths, Richard Buggy, Donal 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. BioMed Central 2017-07-25 Article PeerReviewed Moppett, Iain K., White, Stuart, Griffiths, Richard and Buggy, Donal (2017) 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. Trials, 18 (1). p. 350. ISSN 1745-6215 Humans Hypotension/complications Hypotension/mortality Monitoring Intra-operative Post-operative complications/aetiology Hip fractures/surgery Acute kidney injury/aetiology Arterial pressure https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2066-5 doi:10.1186/s13063-017-2066-5 doi:10.1186/s13063-017-2066-5 |
| spellingShingle | Humans Hypotension/complications Hypotension/mortality Monitoring Intra-operative Post-operative complications/aetiology Hip fractures/surgery Acute kidney injury/aetiology Arterial pressure Moppett, Iain K. White, Stuart Griffiths, Richard Buggy, Donal 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Humans Hypotension/complications Hypotension/mortality Monitoring Intra-operative Post-operative complications/aetiology Hip fractures/surgery Acute kidney injury/aetiology Arterial pressure |
| url | https://eprints.nottingham.ac.uk/48090/ https://eprints.nottingham.ac.uk/48090/ https://eprints.nottingham.ac.uk/48090/ |