Hemodynamic Monitoring and Resuscitation in Hip Fractures

Fracture of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401138
• Other study ID #: H- 17037633
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: October 28, 2019

Study information

• Verified date: October 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Primary acute hip fracture

• Age grater than 65 years

• Written informed consent

Exclusion Criteria:

• Contraindications to epidural analgesia

Related Conditions & MeSH terms

• Fracture of Hip
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Preoperative Stroke Volume(SV)-guided fluid optimization
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.

Locations

Country	Name	City	State
Denmark	Department af Anesthesia, Hvidovre Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia		Preoperatively
Primary	Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia		Preoperatively
Primary	Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%		Preoperatively
Secondary	Correlation between SV, PII and NIRS at normo- and hypovolemia states		Preoperatively
Secondary	Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature		Preoperatively
Secondary	Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb		Preoperatively
Secondary	Proportion of mortality in patients responding to the fluid challenge vs. patients not responding		At 30 days and 1 year
Secondary	Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding		At 30 days and 1 year
Secondary	Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV		At 30 days and 1 year