Hip FractureIOPCNCT01294930
Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture
An observational study of Hip Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Urine density
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hip fracture operated at the hospital in Norrkoeping
Who may be able to join
- patients with hip fracture
- operation for the hip fracture
- informed consent
Who cannot join
- patients not giving consent
- patients not being able to understand information
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hip Fracture
- Being tested
- Urine density
- Keywords
- hip fracture, mortality, complications
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine densityOther
Also called - Urine color, - Urine density, - Plethysmographic variabilty
measurement of urine color, density and plethysmographic variability index before and during surgery.
| Study group | Role | What they receive |
|---|---|---|
| hip fracture | Patients operated for hip fracture, giving informed consent Receives: Other: Urine density |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
30-day mortality related to indices of dehydration (urine and pulse oximetry)
Measured: 30 days
Secondary outcomes (1)
operative and postoperative complications
Number of complications according to a prospective list
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Vrinnevi Hospital
- Responsible party
- Principal investigator, Joachim Zdolsek, University Hospital, Linkoeping
- Investigators
- Robert Hahn, MD PhD Prof, Study director, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294930
- Sponsor's protocol ID
- IOPC
- Acronym
- IOPC
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture
- ClinicalTrials.gov ID
- NCT01294930
- Acronym / sponsor ID
- IOPC / IOPC
- Conditions
- Hip Fracture
- Keywords
- hip fracture, mortality, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Vrinnevi Hospital
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture | – | Other: Urine densityPatients operated for hip fracture, giving informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip fracture operated at the hospital in Norrkoeping
Key inclusion criteria (3 listed)
- patients with hip fracture
- operation for the hip fracture
- informed consent
Key exclusion criteria (2 listed)
- patients not giving consent
- patients not being able to understand information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine densityAlso: - Urine color, - Urine density, - Plethysmographic variabiltymeasurement of urine color, density and plethysmographic variability index before and during surgery. | Other | hip fracture |
Primary outcome
mortality
Time frame: 30 days
30-day mortality related to indices of dehydration (urine and pulse oximetry)
1 secondary outcome
operative and postoperative complications
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Derived from this study: PubMed 24145802Ylinenvaara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hahn, MD PhD Prof study director
University Hospital, Linkoeping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.