Clinical trial NCT01673776: Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture
Official title: Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Femoral Fracture
Keywords: Proximal femoral fracture
multimodal intervention
goal directed therapy (GDT)
hemodynamic intervention
outcome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 132
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.

Detailed description: Femoral neck fractures constitute both a social and economic challenge. The one year mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the major contributor. It is an objective of the present study to investigate whether a multi-modal perioperative intervention can improve the outcome of these patients.

We plan to carry out a prospective randomized controlled clinical study. Patients with an age above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures) are to be included. These are divided into two groups, K and M. General anaesthesia is applied to both groups. In group K a commonly used therapy will be applied whereas in group M an intesified perioperative care will be carried out. The objectives are to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the nutrition of the patients is supplemented with highly caloric drinks.

A primary common endpoint is the appearance of postoperative complications. These include cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary endpoints are mortality, duration of the stay at the hospital and intensive care duration. It is the objective of the study to reduce the probability for at least one postoperative complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be included in the study.

All participants are to be contacted by phone one year after the surgery and their health situation is to be determined.

Eligibility criteria: Inclusion Criteria:

* proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
* Age ≥ 60 years
* written informed consent

Exclusion Criteria:

* pathological fracture
* multiple trauma
* fracture during a hospital stay due to a different disease

Primary outcomes:
measure: postoperative complications
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of 14 days
Secondary outcomes:
measure: mortality
timeFrame: 1 year
measure: duration of the stay at the hospital
timeFrame: 1 year
measure: intensive care duration
timeFrame: 1 year
Other outcomes:
Locations:
city: Munic
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
name: Bettina Jungwirth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
citation: Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
citation: Schmid S, Blobner M, Haas B, Lucke M, Neumaier M, Anetsberger A, Jungwirth B. Perioperative multi-system optimization protocol in elderly hip fracture patients: a randomized-controlled trial. Can J Anaesth. 2019 Dec;66(12):1472-1482. doi: 10.1007/s12630-019-01475-9. Epub 2019 Sep 17.