Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

Hip Fracture Clinical Trial

Official title:

Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280253
• Other study ID #: USILAN-2
• Secondary ID: 20101837
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: November 11, 2016
• Start date: January 2011

Study information

• Verified date: November 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial Summary

The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden

• Informed consent

• Blood sampling within 3 hrs of first contact with healthcare

Exclusion Criteria:

• No consent can be obtained

• Non-operative management

• Followup through the Swedish National Quality for Hip fracture patients not possible

• High energy trauma

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Locations

Country	Name	City	State
Sweden	Skane University Hospital, Lund	Lund	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Anna and Edwin Berger Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days	No
Secondary	Morbidity	Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications	30 day	No