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CompletedNCT01294930IOPCUpdated Feb 21, 2013

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

An observational study in Hip Fracture, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-21.

Sponsored by University Hospital, Linkoeping · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hip Fracture

Keywords

  • hip fracture
  • mortality
  • complications
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 45 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with hip fracture operated at the hospital in Norrkoeping

Inclusion criteria

  • patients with hip fracture
  • operation for the hip fracture
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • patients not giving consent
  • patients not being able to understand information
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • hip fracture

    Patients operated for hip fracture, giving informed consent

    Other: Urine density

Interventions

  • OtherUrine density

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

    Also known as: - Urine color, - Urine density, - Plethysmographic variabilty

06

What researchers measure

Primary outcomes

  1. mortality

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

    Time frame: 30 days

Secondary outcomes

  1. operative and postoperative complications

    Number of complications according to a prospective list

    Time frame: 3 days

07

Study locations

1 site
  • Anaesthesia dept, Vrinnevisjukhuset
    Norrkoeping, Sweden
08

References and documents

Publications

  • 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. PubMed 24145802 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01294930
Lead sponsor
University Hospital, Linkoeping
Collaborators
Vrinnevi Hospital
Responsible party
Joachim Zdolsek (MD, PhD, University Hospital, Linkoeping) — Principal investigator
First posted
Feb 14, 2011
Start date
Jan 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Feb 21, 2013

Study contacts

Robert Hahn, MD PhD Prof
study director · University Hospital, Linkoeping

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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