- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Norrkoeping, Sverige
- Anaesthesia dept, Vrinnevisjukhuset
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
mortality
Tidsramme: 30 days
|
30-day mortality related to indices of dehydration (urine and pulse oximetry)
|
30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
operative and postoperative complications
Tidsramme: 3 days
|
Number of complications according to a prospective list
|
3 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Robert Hahn, MD PhD Prof, University Hospital, Linkoeping
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IOPC
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