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NCT Number: NCT03401138

Hemodynamic Monitoring and Resuscitation in Hip Fractures

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department af Anesthesia, Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to epidural analgesia

Treatment and study plan

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.

Other names: Blood volume measurement, Monitoring of Peripheral Perfusion Index (PPI), Monitoring of Near-infrared Spectroscopy (NIRS)

Primary outcomes

  1. Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia

    Time frame: Preoperatively

  2. Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia

    Time frame: Preoperatively

  3. Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%

    Time frame: Preoperatively

Secondary outcomes

  1. Correlation between SV, PII and NIRS at normo- and hypovolemia states

    Time frame: Preoperatively

  2. Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature

    Time frame: Preoperatively

  3. Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb

    Time frame: Preoperatively

  4. Proportion of mortality in patients responding to the fluid challenge vs. patients not responding

    Time frame: At 30 days and 1 year

  5. Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding

    Time frame: At 30 days and 1 year

  6. Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV

    Time frame: At 30 days and 1 year

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2018
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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