Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture

Hip Fracture Clinical Trial

— IOPC  

Official title:

Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294930
• Other study ID #: IOPC
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: February 20, 2013
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

Patients operated for hip fractures are older and have several conditions that have negative influences on the perioperative and postoperative prognosis.

Hip fractures can also be painful, which is stressful for the physiology of the patient. Many old patients have received to little fluid intake. They often have diuretic therapy, which even worsens dehydration/hypovolemia.

Some patients have to wait several days for surgery. Several studies have shown a high degree of complications and an increased mortality in this patient group.

Early preoperative optimization can improve the outcome. The available methods for optimization of the patient are complicated and time consuming.

The investigators wish with this study to try new approaches to find which patients still are dehydrated when they come to the operation ward.

The aim is to measure the color and density of the urine as well as to register the the variability in the plethysmographic curve before spinal anaesthesia.

These results will be compared to circulatory instability during and after surgery as well as to postoperative complications.

Description:

All patients with hip fractures planed fore surgery at the Hospital in Norrkoping will come into consideration to participate in study.

Many will however not be able to give consent. These will not be included in the study.

Directly preoperatively urine will be collected. Color and density will be measured/registered.

The pulseoximeter reading will be registered (Saturation, pulse, PI and PVI) before spinal anaesthesia and after spinal anaesthesia as well as during the surgery.

Two to three days postoperatively a follow up will be performed, to register complications (Circulatory instability, confusion, infection, affected kidney function/creatinine rise).

30 day postoperative mortality will also be controlled.

These results will be compared, to see if pulse oximeter readings or urine concentration can predict complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with hip fracture

• operation for the hip fracture

• informed consent

Exclusion Criteria:

• patients not giving consent

• patients not being able to understand information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Postoperative Complications

Intervention

Other:
• Urine density
measurement of urine color, density and plethysmographic variability index before and during surgery.

Locations

Country	Name	City	State
Sweden	Anaesthesia dept, Vrinnevisjukhuset	Norrkoeping

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Vrinnevi Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	30-day mortality related to indices of dehydration (urine and pulse oximetry)	30 days	Yes
Secondary	operative and postoperative complications	Number of complications according to a prospective list	3 days	Yes