What is the clinical evidence from this study?

Study design: RCT. Population: Hip fracture (n=75). Intervention: Tight intra-operative blood pressure control vs. Standard care. Primary outcome: Composite of cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium).

July 25, 2017TrialsOpen Access

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

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Key result

This paper is a study protocol for a pilot randomized controlled trial investigating tight intra-operative blood pressure control in elderly patients undergoing hip fracture repair, and contains no clinical results.

Why the study?

Does tight intra-operative blood pressure control reduce a composite of cardiovascular, renal, and delirium morbidity in elderly patients undergoing hip fracture repair?

Population

75 planned patients aged >70 years, cognitively intact, able to give informed consent, and admitted directly…

Comparison

Tight intra-operative blood pressure control. vs Standard care.

Design

1:1 computer-generated in blocks of unequal size, stratified by intended mode…

Follow-up

30 days (mortality assessed at 1 year)

Authors

IMIain MoppettUniversity of Nottingham SWStuart WhiteRoyal Sussex County Hospital RGR. GriffithsAneurin Bevan University Health Board

Discussion

Member takes

Implication

Feasibility of tight intraoperative BP control RCT shown in hip fracture surgery; supports larger trials to test clinical outcomes.

Study Design

Type

RCT (n=75)

Blinding

Double-blind

Randomization

Computer-generated in blocks of unequal size

Multicenter

Yes

Structured PICO

Does tight intra-operative blood pressure control reduce a composite of cardiovascular, renal, and delirium morbidity in elderly patients undergoing hip fracture repair?

Population

75 planned participants aged >70 years with a primary hip fracture requiring operative repair, cognitively intact and able to give informed consent.

Intervention

Tight intra-operative blood pressure control (active treatment using fluid bolus, ephedrine, or metaraminol to maintain systolic arterial pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout surgery).

Comparator

Standard care (routine intra-operative blood pressure control with fluids and vasopressor drugs used as deemed clinically appropriate by the attending anaesthetist).

Outcome

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).composite

This pilot study protocol outlines a randomized trial to evaluate the feasibility of tight intra-operative blood pressure control for reducing early post-operative ischemic complications in elderly patients undergoing hip fracture repair.

Limitations

Small-scale pilot study
Attending anaesthetist cannot be blinded
Excludes patients who lack capacity
Patients who lack capacity are excluded, which excludes the group that may have most to gain from the intervention
Unavoidably not blinded for the attending anaesthetist
Intervention is limited solely to the period of anaesthesia and not extended to the recovery or ward phases

Cite This Study

Moppett et al. (2017) conducted an RCT in Hip fracture (n=75). Tight intra-operative blood pressure control vs. Standard care was evaluated on Composite of cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). This paper is a study protocol for a pilot randomized controlled trial investigating tight intra-operative blood pressure control in elderly patients undergoing hip fracture repair, and contains no clinical results.

synapsesocial.com/papers/6a78c3eec5ab23c76ced7ead https://doi.org/10.1186/s13063-017-2066-5

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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

Discussion

Member takes

Implication

Study Design

Structured PICO

Limitations

Cite This Study

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

Discussion

Member takes

Implication

Study Design

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider