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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294930
First Posted: February 14, 2011
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vrinnevi Hospital
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
  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:


Further study details as provided by Joachim Zdolsek, University Hospital, Linkoeping:

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


Secondary Outcome Measures:
  • operative and postoperative complications [ Time Frame: 3 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01294930     History of Changes
Other Study ID Numbers: IOPC
First Submitted: February 11, 2011
First Posted: February 14, 2011
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Joachim Zdolsek, 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