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

This study has been completed.
Sponsor:
Collaborator:
Vrinnevi Hospital
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01294930
First received: February 11, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Hip Fracture
 Other: Urine density

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    30-day mortality related to indices of dehydration (urine and pulse oximetry)


Secondary Outcome Measures:
  • operative and postoperative complications [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Number of complications according to a prospective list


Biospecimen Retention:   None Retained

Urine


Enrollment: 45
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hip fracture operated at the hospital in Norrkoeping

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294930

Locations
Sweden
Anaesthesia dept, Vrinnevisjukhuset
Norrkoeping, Sweden
Sponsors and Collaborators
University Hospital, Linkoeping
Vrinnevi Hospital
Investigators
Study Director: Robert Hahn, MD PhD Prof University Hospital, Linkoeping
  More Information

No publications provided

Responsible Party: Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01294930     History of Changes
Other Study ID Numbers: IOPC
Study First Received: February 11, 2011
Last Updated: February 20, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
hip fracture
mortality
complications

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Postoperative Complications
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013