- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Norrkoeping, Sverige
- Anaesthesia dept, Vrinnevisjukhuset
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
hip fracture
Patients operated for hip fracture, giving informed consent
|
measurement of urine color, density and plethysmographic variability index before and during surgery.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
mortality
Tidsramme: 30 days
|
30-day mortality related to indices of dehydration (urine and pulse oximetry)
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
operative and postoperative complications
Tidsramme: 3 days
|
Number of complications according to a prospective list
|
3 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Robert Hahn, MD PhD Prof, University Hospital, Linkoeping
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IOPC
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