Hemodynamic Monitoring and Resuscitation in Hip Fractures

Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Fracture of Hip
• Intervention / Treatment: Other: Preoperative Stroke Volume(SV)-guided fluid optimization

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Department af Anesthesia, Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting a primary acute HF within the study period will be screened for participation by the attending anesthesiologist at the post-anesthesia care unit. The study manager will verify the inclusion and exclusion criteria and inform patients (verbally and in writing) and confirm their agreement to participate by asking them to sign the informed consent document. Assessment of electronic patient records, monitoring and resuscitation treatment and recording of data will be by the study manager.

Description

Inclusion Criteria:

• Primary acute hip fracture
• Age grater than 65 years
• Written informed consent

Exclusion Criteria:

- Contraindications to epidural analgesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia	Preoperatively
Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia	Preoperatively
Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%	Preoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between SV, PII and NIRS at normo- and hypovolemia states	Preoperatively
Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature	Preoperatively
Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb	Preoperatively
Proportion of mortality in patients responding to the fluid challenge vs. patients not responding	At 30 days and 1 year
Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding	At 30 days and 1 year
Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV	At 30 days and 1 year

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Director: Nicolai Bang Foss, Clinical Professor, Department of Anesthesia, Hvidovre Hospital; Study Chair: Jakob Højlund, MD, Senior Hospital Physiscian, Department of Anesthesia, Hvidovre Hospital; Study Chair: Henrik Sørensen, MD, DMSc, Abdominal Centre, Department of Anesthesia, Rigshospitalet; Study Chair: Niels Secher, Professor, DMSc, Abdominal Centre, Department of Anesthesia, Rigshospitalet; Principal Investigator: Marianne Agerskov, MD, Research Fellow, Department of Anesthesia, Hvidovre Hospital

Publications and helpful links

General Publications

• Agerskov M, Sorensen H, Hojlund J, Secher NH, Foss NB. Pre-operative haemodynamic monitoring and resuscitation in hip fracture patients: Protocol for a prospective observational study. Acta Anaesthesiol Scand. 2018 Oct;62(9):1314-1320. doi: 10.1111/aas.13163. Epub 2018 May 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2018
• Primary Completion (ACTUAL): October 28, 2019
• Study Completion (ACTUAL): October 28, 2019

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (ACTUAL): January 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hemodynamic monitoring; Near-infrared spectroscopy; Hemodynamic optimization; Blood Volume; Peripheral perfusion; Tissue Prefusion; Preoperative resuscitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: H- 17037633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No