Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture

NCT ID: NCT01673776

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-10-15

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.

Conditions

Proximal Femoral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

K group

commonly used therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

M group

multimodal intervention

Group Type: EXPERIMENTAL

PulsioFlex® Monitoring

Intervention Type: DEVICE

• goal directed therapy according to PulsioFlex® Monitoring- measurements
• femoral catheter
• extended perioperative monitoring
• nutritional supplementation, (if necessary)

Interventions

PulsioFlex® Monitoring

• goal directed therapy according to PulsioFlex® Monitoring- measurements
• femoral catheter
• extended perioperative monitoring
• nutritional supplementation, (if necessary)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Jungwirth, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

Locations

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 19054201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20966436 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31531828 (View on PubMed)

Other Identifiers

FEMO

Identifier Type: -

Identifier Source: org_study_id