Acute confusional state in elderly patients with a broken hip

Delirium in Elderly Patients with Trauma of the Hip - DEPTHip Study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003650-40-NL

Enrollment

340

Registered

2015-11-19

Start date

2015-12-01

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip fracture MedDRA version: 21.1 Level: LLT Classification code 10053220 Term: Hip injury System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10033432 Term: Pain in hip System Organ Class: 100000004859

Interventions

Trade Name: Bupivacaine Hydrochloride Product Name: Bupivacaine Hydrochloride Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 55 years and older - hip fracture Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340

Exclusion criteria

Exclusion criteria: - multiple injuries (polytrauma patients) - previous adverse reaction or known allergy to local anaesthetics or opioids or paracetamol - delirious at presentation in the ED

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To investigate effectiveness in pain treatment, satisfaction of patients and staff, functional evaluation and an economic evaluation.;Primary end point(s): The primary outcome is the occurrence of delirium during the entire hospital stay, until three months after discharge from the hospital. ;Main Objective: To investigate whether the use of a continuous ultrasound-guided Fascia Iliaca Compartment Block employing catheter technique, administered in the ED within 2 hours after presentation of an elderly patient with a hip fracture, can decrease the incidence of delirium during the clinical course (hospital admission) and the first three months after discharge from the hospital. ; Timepoint(s) of evaluation of this end point: Phase 1 in the ED: Delirium is assessed using the Confusion Assessment Method (exclusion criterium) Phase 2 in the hospital: Delirium is continuously screened during hospital stay by using Delirium Observation Screening Scale (DOSS) during each nursing shift and the CAM and CAM-ICU in surgery, recovery and ICU. Phase 3 after discharge: Delirium is assessed at 1 and 3 months after discharge	—

Measure

Time frame

Secondary Objective: To investigate effectiveness in pain treatment, satisfaction of patients and staff, functional evaluation and an economic evaluation.;Primary end point(s): The primary outcome is the occurrence of delirium during the entire hospital stay, until three months after discharge from the hospital. ;Main Objective: To investigate whether the use of a continuous ultrasound-guided Fascia Iliaca Compartment Block employing catheter technique, administered in the ED within 2 hours after presentation of an elderly patient with a hip fracture, can decrease the incidence of delirium during the clinical course (hospital admission) and the first three months after discharge from the hospital. ; Timepoint(s) of evaluation of this end point: Phase 1 in the ED: Delirium is assessed using the Confusion Assessment Method (exclusion criterium) Phase 2 in the hospital: Delirium is continuously screened during hospital stay by using Delirium Observation Screening Scale (DOSS) during each nursing shift and the CAM and CAM-ICU in surgery, recovery and ICU. Phase 3 after discharge: Delirium is assessed at 1 and 3 months after discharge

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Secondary

Measure	Time frame
Secondary end point(s): - Duration (defined as the total number of days with delirium) and the severity (percentage of patients with duration > 2 days) of delirium; - Pain (NRS pain scores during complete hospital stay, as well as need for rescue analgesia); - Satisfaction of patients and health care staff regarding efficacy of pain treatment and method of pain treatment in the ED and daily during hospital admission (5-point Likert scales and reference questions); - Hospital stay characteristics (length of stay, ICU admission and ICU length of stay, hospital re-admission rate, occurrence of complications of hip surgery and medical complications, all cause in-hospital-mortality and mortality after hospital discharge); - Functional status: - (15-item modified Katz Index of Activities of Daily Living) based on 2 weeks before presentation and after 3 months; - The Oxford Hip Score after 3 months; - Generic HRQol (Euroqol - EQ-5D-5L) at 3 months; - Cognitive function (Mini Mental State Examination at inclusion, at discharge and at 3 months; - Economic evaluation (cost-effectiveness and cost-utility analysis), QALY's calculated by product sum of utility of each health state (EQ-5D-5L) and times in between observations, direct and indirect medical and non-medical costs, health-related costs of patients and family; Baseline parameters are: time of presentation at Emergency Department and time to application of the intervention or administration of analgesics, age, sex, medical history and medication use, type of hip fracture (medial or lateral collum fracture, per- or inter-trochanteric). ; Timepoint(s) of evaluation of this end point: Phase 1 in the ED: baseline characteristics are documented, as well as baseline pain scores and initial pain scores after the initiation of pain treatment	—

Measure

Time frame

Secondary end point(s): - Duration (defined as the total number of days with delirium) and the severity (percentage of patients with duration > 2 days) of delirium; - Pain (NRS pain scores during complete hospital stay, as well as need for rescue analgesia); - Satisfaction of patients and health care staff regarding efficacy of pain treatment and method of pain treatment in the ED and daily during hospital admission (5-point Likert scales and reference questions); - Hospital stay characteristics (length of stay, ICU admission and ICU length of stay, hospital re-admission rate, occurrence of complications of hip surgery and medical complications, all cause in-hospital-mortality and mortality after hospital discharge); - Functional status: - (15-item modified Katz Index of Activities of Daily Living) based on 2 weeks before presentation and after 3 months; - The Oxford Hip Score after 3 months; - Generic HRQol (Euroqol - EQ-5D-5L) at 3 months; - Cognitive function (Mini Mental State Examination at inclusion, at discharge and at 3 months; - Economic evaluation (cost-effectiveness and cost-utility analysis), QALY's calculated by product sum of utility of each health state (EQ-5D-5L) and times in between observations, direct and indirect medical and non-medical costs, health-related costs of patients and family; Baseline parameters are: time of presentation at Emergency Department and time to application of the intervention or administration of analgesics, age, sex, medical history and medication use, type of hip fracture (medial or lateral collum fracture, per- or inter-trochanteric). ; Timepoint(s) of evaluation of this end point: Phase 1 in the ED: baseline characteristics are documented, as well as baseline pain scores and initial pain scores after the initiation of pain treatment

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Countries

Netherlands

Contacts

Public ContactM.L. Ridderikhof

Amsterdam UMC, locatie AMC

m.l.ridderikhof@amsterdamumc.nl00310205660973

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026