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

Sponsor
University Hospital, Linkoeping (Other)
Overall Status
Completed
CT.gov ID
NCT01294930
Collaborator
Vrinnevi Hospital (Other)
45
1
18
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Urine density

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
hip fracture

Patients operated for hip fracture, giving informed consent

Other: Urine density
measurement of urine color, density and plethysmographic variability index before and during surgery.
Other Names:
  • - Urine color
  • - Urine density
  • - Plethysmographic variabilty
  • Outcome Measures

    Primary Outcome Measures

    1. mortality [30 days]

      30-day mortality related to indices of dehydration (urine and pulse oximetry)

    Secondary Outcome Measures

    1. operative and postoperative complications [3 days]

      Number of complications according to a prospective list

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaesthesia dept, Vrinnevisjukhuset Norrkoeping Sweden

    Sponsors and Collaborators

    • University Hospital, Linkoeping
    • Vrinnevi Hospital

    Investigators

    • Study Director: Robert Hahn, MD PhD Prof, University Hospital, Linkoeping

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT01294930
    Other Study ID Numbers:
    • IOPC
    First Posted:
    Feb 14, 2011
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2013