NCT03401138

Hemodynamic Monitoring and Resuscitation in Hip Fractures

Completed Last updated 30 October 2019

What this trial tests

trial testing Preoperative Stroke Volume(SV)-guided fluid optimization in Fracture of Hip in 50 participants. Completed in 28 October 2019.

Timeline

14 February 2018

Primary endpoint
28 October 2019

28 October 2019

Quick facts

Lead sponsor	Hvidovre University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	14 February 2018
Primary completion	28 October 2019
Estimated completion	28 October 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Preoperative Stroke Volume(SV)-guided fluid optimization

Conditions studied

• Fracture of Hip — all drugs for Fracture of Hip →

Sponsor

Hvidovre University Hospital

Who can join

65 and older, any sex, with Fracture of Hip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion strategy is available. An important goal of hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and blood volume and a decreased peripheral perfusion index predicts surgical complications and morbidity in acute surgical and septic shock patients. The research group hypothesize that elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation and that the non-invasive peripheral perfusion index will serve as an early predictor of a deteriorated circulation in reflection of stroke volume.

Methods: The main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. The secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. Fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. All patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy.

Discussion: This is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. The study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.