Effects of Fast-tracking Geriatric Hip Fracture Patients
Primary Purpose
Hip Fracture
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fast-tracking
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Fracture focused on measuring hip fracture, fast-tracking, complications
Eligibility Criteria
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
Sites / Locations
- Sahlgrenska University Hospital, Mölndal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fast-tracking at geriatric medicine ward
Regular admission
Arm Description
Fast-tracking hip fracture patients at geriatric medicine ward. The goal is to optimize the medical care of older hip fracture patients at a geriatric ward and to shorten the time to operation.
Regular admission and care of hip fracture patients at the emergency room prior to surgery.
Outcomes
Primary Outcome Measures
Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04755686
First Posted
June 10, 2013
Last Updated
February 12, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04755686
Brief Title
Effects of Fast-tracking Geriatric Hip Fracture Patients
Official Title
Effects of Fast-tracking Hip Fracture Patients in Geriatric Medicine Wards on Complication Incidence and Time of Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture, fast-tracking, complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fast-tracking at geriatric medicine ward
Arm Type
Experimental
Arm Description
Fast-tracking hip fracture patients at geriatric medicine ward. The goal is to optimize the medical care of older hip fracture patients at a geriatric ward and to shorten the time to operation.
Arm Title
Regular admission
Arm Type
No Intervention
Arm Description
Regular admission and care of hip fracture patients at the emergency room prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Fast-tracking
Primary Outcome Measure Information:
Title
Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality)
Time Frame
at time of discharge from geriatric medicine ward, after four months and after one year
Secondary Outcome Measure Information:
Title
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
Time Frame
At time of discharge from geriatric medicine ward, after four months and after one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Lorentzon, MD, PhD
Organizational Affiliation
Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital, Mölndal
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effects of Fast-tracking Geriatric Hip Fracture Patients
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