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

NCT ID: NCT01294930

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hip Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hip fracture

Patients operated for hip fracture, giving informed consent

Urine density

Intervention Type OTHER

measurement of urine color, density and plethysmographic variability index before and during surgery.

Interventions

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Urine density

measurement of urine color, density and plethysmographic variability index before and during surgery.

Intervention Type OTHER

Other Intervention Names

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- Urine color - Urine density - Plethysmographic variabilty

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrinnevi Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Joachim Zdolsek

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Hahn, MD PhD Prof

Role: STUDY_DIRECTOR

University Hospital, Linkoeping

Locations

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Anaesthesia dept, Vrinnevisjukhuset

Norrköping, Norrkoeping, Sweden

Site Status

Countries

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Sweden

References

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Ylinenvaara SI, Elisson O, Berg K, Zdolsek JH, Krook H, Hahn RG. Preoperative urine-specific gravity and the incidence of complications after hip fracture surgery: A prospective, observational study. Eur J Anaesthesiol. 2014 Feb;31(2):85-90. doi: 10.1097/01.EJA.0000435057.72303.0e.

Reference Type DERIVED
PMID: 24145802 (View on PubMed)

Other Identifiers

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IOPC

Identifier Type: -

Identifier Source: org_study_id

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