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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04755686
Other study ID # dnr 154-13
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date June 2017

Study information

Verified date February 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.


Description:

Each year about 18000 persons in Sweden suffer from a hip fracture. These people are often among the oldest and have many complicating diseases. The one-year mortality after hip fracture is 20%. Due to the complexity including many comorbidities in these patients, it is of great value that the care of these patients is optimal. Today, most of the patients with suspected hip fracture in the catchment area of Sahlgrenska University hospital, Gothenburg, are transported directly to the radiology unit. Thereafter, the patient waits in the emergency room (ER) for an othopedic examination before being admitted to primarily a geriatric medicine ward where they wait for the operation. The average waiting time in the ER is today around four hours. The current scientific evidence for fast-tracking hipfracture patients is limited. The aim of our randomized controlled trial is to determine the effect of fast-tracking hip fracture patients at geraitric medicine wards compared to standard care regarding complication rate (primary endpoint), lenght of hospital stay and time to operation (secondary outcomes).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - patients with low energy trauma with pain at the hip and/or groin AND - respiratory frequency: 8-25/minute AND - saturation: 90% or higher on air AND - pulse: 50-119 beats per minute AND - systolic blood pressure: >90 mmHg AND - level of consciousness: Reaction level scale (RLS) 1 or Glasgow Coma Scale (GCS) 14-15 AND - plasma-glucose: 3,0-25 mmol/l Exclusion Criteria: We will exclude patients based on the following criteria: - distal status affected - suspicion of other simultaneous fracture - suspicion of head trauma or affected consciousness - suspicion of acute cardiac disease - signs of acute cardiac ischemia in electrocardiogram - generalized symtoms, except for pain in the hip

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Fast-tracking


Locations

Country Name City State
Sweden Sahlgrenska University Hospital, Mölndal Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality) at time of discharge from geriatric medicine ward, after four months and after one year
Secondary Length of hospital stay, time to operation, all-cause mortality, functional ability after discharge, proportion of patients returning to former living, self assessed health status At time of discharge from geriatric medicine ward, after four months and after one year
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