- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294930
Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture (IOPC)
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Norrkoeping, Sweden
- Anaesthesia dept, Vrinnevisjukhuset
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
hip fracture
Patients operated for hip fracture, giving informed consent
|
measurement of urine color, density and plethysmographic variability index before and during surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: 30 days
|
30-day mortality related to indices of dehydration (urine and pulse oximetry)
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative and postoperative complications
Time Frame: 3 days
|
Number of complications according to a prospective list
|
3 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Robert Hahn, MD PhD Prof, University Hospital, Linkoeping
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOPC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fracture
-
University Health Network, TorontoNot yet recruitingSurgery | Hip-fracture
-
Lund UniversityMalmo Municipality, SwedenRecruiting
-
Hvidovre University HospitalCompleted
-
Michal Roll PhD,MBATel-Aviv Sourasky Medical CenterUnknown
-
The University of Hong KongRecruiting
-
Mayo ClinicCompletedPertrochanteric Hip FractureUnited States
-
Eurofarma Laboratorios S.A.TerminatedHip Fracture SurgeryBrazil
-
National Institute of Arthritis and Musculoskeletal...Completed
-
AO Clinical Investigation and Publishing DocumentationCompletedHip Fractures | Closed Fracture of HipIsrael, Austria, Switzerland, Germany, Belgium, Norway
Clinical Trials on Urine density
-
Assistance Publique - Hôpitaux de ParisIntergroupe Francophone du MyelomeRecruiting
-
Children's Hospital of Fudan UniversityKunshan City Maternal and Child Health Hospital; Qidong City Maternal and Child...RecruitingKidney Diseases | Child, Only | Urinalysis | Ultrasound | Diagnostic TechniquesChina
-
Memorial Sloan Kettering Cancer CenterNovartisCompletedLeukemia | Gastric Cancer | Chronic Myelogenous LeukemiaUnited States
-
Universitair Ziekenhuis BrusselRecruitingFrailty | Asymptomatic Bacteriuria | Geriatric Syndrome | SIADHBelgium
-
Gayle GordilloNationwide Children's HospitalCompletedHemangiomaUnited States
-
Jason HafronWilliam Beaumont HospitalsTerminatedRenal Cell CarcinomaUnited States
-
Atatürk UniversityCompletedCalcium Metabolism Disorders | Bone Turnover Rate DisorderTurkey
-
University of Alabama at BirminghamChildren's Hospital Medical Center, CincinnatiCompletedAcute Kidney Injury | Nephrotoxicity | NeonatalUnited States
-
Children's Hospital of PhiladelphiaPatient-Centered Outcomes Research Institute; Johns Hopkins University; University... and other collaboratorsEnrolling by invitationChronic Kidney Disease Stage 3 | Pediatric Kidney Disease | Chronic Kidney Disease Stage 2United States
-
Assiut UniversityEnrolling by invitation