Trial document
DRKS00013644
Trial Description
Title
Improve Hip Fracture Outcome In The Elderly Patient (iHOPE): a multicentre randomized controlled trial to test the efficacy of spinal versus general anaesthesia
Trial Acronym
iHOPE
URL of the Trial
[---]*
Brief Summary in Lay Language
iHOPE aims to evaluate the effect of two different standard anaesthesia care approaches (spinal and general anaesthesia) for hip fracture surgery on the outcomes of patients up to 365 ± 60 days. iHOPE aims to optimize the efficacy, clinical and cost effectiveness of anaesthesia care for hip fracture patients.
Brief Summary in Scientific Language
This is a pragmatic, confirmatory, comparative, national, multicentre, actively controlled, randomized, open-label, prospective, parallel-group study that will enroll 1032 patients with hip fracture (femoral neck or intertrochanteric fracture) needing surgical treatment.
The aim of this study is to optimize patient care. For this purpose, spinal and general anesthesia with regard to recovery and mental (postoperative delirium, depression and satisfaction with treatment) and physical (mortality, regaining running and self-reliance, severe new comorbidities) health status of elderly patients after their hip replacement surgery will be compared.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00013644
- 2018/04/10
- [---]*
- yes
- Approved
- EK 022/18, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
Secondary IDs
- [---]*
Health Condition or Problem studied
- S70-S79 - Injuries to the hip and thigh
Interventions/Observational Groups
- Hip fracture surgery with standard care general anaesthesia
- Hip fracture surgery with standard care spinal anaesthesia
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
To test Efficacy of spinal versus general anaesthesia on allcause mortality and new-onset (i.e. not pre-existing at time of surgery) serious cardiac and pulmonary complications up to 30-days after hip fracture surgery.
Secondary Outcome
1) Difference in the proportion of patients alive and delirium free in the first 4 days after hip fracture surgery. Delirium will be assessed via in-person interview by the validated, high sensitive and specific assessment tool 3D-Confusion Assessment Method (3D-CAM). It will be applied at baseline and daily on the first 4 postoperative days.
2) Difference in the proportion of patients with postoperative pain; and in the characteristics and duration of postoperative pain between the two treatment arms. Pain will be assessed via numeric rating scale (NRS 0-10) and questions derived from the Brief Pain Inventory and the German pain questionnaire. Assessment will be performed via in-person interview at baseline and each postoperative visit during hospital stay. After discharge, it will be performed via telephone interview at each follow-up visit.
3) Difference in the satisfaction with care between the two treatment arms, assessed at day 4 or the day of discharge (whichever occurs first). The Bauer Patient Satisfaction Questionnaire will be used via in-person interview on postoperative day 4 or at discharge (whichever occurs first), to assess the patients´ satisfaction.
4) Difference in the number of in-hospital events, which include (but not limited to): Planned and unplanned admission to critical care; length of hospital and intensive care stay; length of hospital stay longer than expected; independence in walking and the need for assistive devices for walking at hospital discharge; postoperative hospital discharge destination; in hospital all-cause mortality and severe new-onset complications as those used by the NSQIP. These events will be assessed on the discharge day from hospital or at least at postoperative day 30 via in-person interview and medical record review.
5) Difference in the proportion or means of long-term outcomes at day 30 ± 3, day 180 ± 45 and day 365 ± 60 after randomization will include: All cause-mortality, independence in walking and need for assistive devices for walking; chronic pain; ability to return home; cognitive function via Short blessed test (SBT); and overall health and disability via World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Except of the cognitive function and chronic pain, which could only be assessed via telephone interview of the patient, all other data could also be assessed via telephone interview of the proxy.
6) Difference in the proportion of patients with perioperative serious adverse events like intraoperative cardiac arrest; malignant hyperthermia; intraoperative anaphylaxis; intraoperative aspiration; total spinal anaesthesia; epidural hematoma; paralysis of the lower extremities lasting greater than 24 hours following spinal anaesthesia; fall within 12 hours of anaesthesia care. These data will be assessed during the surgery and the postoperative in-hospital visits via in-person interview and medical record review.
7) Sensitivity and subgroup analyses of the primary outcome will consider the baseline proportion of patients with depression and frailty. Depression will be assessed via the 15-items short version of the Geriatric Depression Scale (GDS) at baseline via in-person interview. Frailty assessment will be performed according to phenotype-model of Fried at baseline via in-person interview. Four of originally five Fried-criteria will be assessed: fatigue, maximal grip strength assessment of the dominant hand, physical activity (employing the Minnesota Leisure Time Activities Questionnaire) and weight loss in the past year. Gait velocity as the fifth Fried criterion will be omitted in this study for obvious reasons.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- Medical Center
- University Medical Center
- Medical Center
- Medical Center
- University Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2018/04/25
- 1032
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 65 Years
- no maximum age
Additional Inclusion Criteria
Age ≥ 65 years; signed informed consent; suffers from intra-/extracapsular hip fracture (e.g. femoral neck fracture, subtrochanteric or intertrochanteric fracture), planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate osteosynthetic procedure
Exclusion Criteria
People who are institutionalized by court or administrative order;
planned concurrent surgery not amenable to spinal anaesthesia;
absolute contraindications to spinal anaesthesia; periprosthetic
fracture; prior participation in the iHOPE study; as determined by the
attending surgeon, the attending anaesthesiologist, or the site
principle investigator or their designate, that the patient or the
attending team would not be suitable for a randomization procedure
Addresses
-
start of 1:1-Block address primary-sponsor
- Klinik für Anästhesiologie, Uniklinik RWTH Aachen
- Mr. Prof. Dr. med. Mark Coburn
- Pauwelsstr. 30
- 52074 Aachen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 241 80 88179
- [---]*
- mcoburn at ukaachen.de
- https://www.ukaachen.de/kliniken-institute/klinik-fuer-anaesthesiologie.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Center for Translational & Clinical Research Aachen (CTC-A), Uniklinik RWTH Aachen
- Mr. Dr. Rainer Schuckelt
- Pauwelsstr. 30
- 52074 Aachen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- + 49 241 80 80092
- [---]*
- rschuckelt at ukaachen.de
- http://www.medizin.rwth-aachen.de/cms/Medizin/Die-Fakultaet/Einrichtungen/~coen/Klinisches-Studienzentrum-Aachen/
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Klinik für Anästhesiologie, Uniklinik RWTH Aachen
- Mr. Prof. Dr. med. Mark Coburn
- Pauwelsstr. 30
- 52074 Aachen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 241 80 88179
- +49 241 80 82593
- mcoburn at ukaachen.de
- https://www.ukaachen.de/kliniken-institute/klinik-fuer-anaesthesiologie.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address scientific-contact
- Uniklinik RWTH Aachen, Klinik für Anästhesiologie
- Ms. Dr. med. Ana Kowark
- Pauwelsstr. 30
- 52074 Aachen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 241 80 35766
- +49 241 80 3335766
- akowark at ukaachen.de
- https://www.ukaachen.de/kliniken-institute/klinik-fuer-anaesthesiologie.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Uniklinik RWTH Aachen, Klinik für Anästhesiologie
- Mr. Prof. Dr. med. Mark Coburn
- Pauwelsstr. 30
- 52074 Aachen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 241 80 88179
- +49 241 80 82593
- mcoburn at ukaachen.de
- https://www.ukaachen.de/kliniken-institute/klinik-fuer-anaesthesiologie.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
- [---]*
- [---]*
- [---]*
- [---]*
Trial Publications, Results and other Documents
- [---]*