NCT01294930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

February 11, 2011

Last Update Submit

February 20, 2013

Conditions

Keywords

hip fracturemortalitycomplications

Outcome Measures

Primary Outcomes (1)

  • mortality

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

    30 days

Secondary Outcomes (1)

  • operative and postoperative complications

    3 days

Study Arms (1)

hip fracture

Patients operated for hip fracture, giving informed consent

Other: Urine density

Interventions

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hip fracture operated at the hospital in Norrkoeping

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthesia dept, Vrinnevisjukhuset

Norrköping, Norrkoeping, Sweden

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: NONE RETAINED

Urine

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Robert Hahn, MD PhD Prof

    University Hospital, Linkoeping

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations