Hemodynamic Monitoring and Resuscitation in Hip Fractures

NCT03401138 | Completed DMC

• 1 other identifier: H- 17037633
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture of Hip

Keywords

Peripheral perfusion; Blood Volume; Tissue Prefusion; Near-infrared spectroscopy; Hemodynamic monitoring; Hemodynamic optimization; Preoperative resuscitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Interventions

Preoperative Stroke Volume(SV)-guided fluid optimization OTHER

Preoperative SV-guided hemodynamic optimization will be commenced with patients receiving 250ml fluid challenges over five minutes aiming to maximize SV. Maximal SV is defined as absence of a sustained rise in SV by at least 10% in response to a fluid challenge. PPI will be obtained from the Masimo Radical 7 (Masimo, Irvine, CA, USA) and NIRS from Invos 5100C (Medtronic, Minneapolis, MN, USA). BV measurements will use pulse dye densitometry (PDD) with Indocyanine Green (ICG). We will use the Dye Densitogram 3300 analyser Nihon Kohden (Tokyo, Japan) for registration of the spectrophotometrical absorption of ICG and calculation of BV.

Also known as: Blood volume measurement, Monitoring of Peripheral Perfusion Index (PPI), Monitoring of Near-infrared Spectroscopy (NIRS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Contraindications to epidural analgesia

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Department af Anesthesia, Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 29851062 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Nicolai Bang Foss, Clinical Professor

  Department of Anesthesia, Hvidovre Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• Marianne Agerskov, MD, Research Fellow

  Department of Anesthesia, Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Reseach Fellow

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 17, 2018
• Study Start: February 14, 2018
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)