Delirium - PostoperativePhase 4NCT02317601
Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery
A Phase 4 study testing methylprednisolone sodium succinate in people with Delirium - Postoperative and Stress, Physiological, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative, Stress, Physiological
- What is being tested?
- methylprednisolone sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients undergoing surgery for hip fracture
- Informed signed consent
- Danish speaking
Who cannot join
- Allergies towards contents of Solu-Medrol
- Insulin dependent diabetes
- Glaucoma
- In treatment for cancer disease
- Positive HIV, Hepatitis b or C status
- Lack of informed consent (eq. Severe dementia, coma, and others)
Show all 10Show fewer
- Current treatment with systemic glucocorticoids (pr.os or intravenous) Immunoinflammatory disease (Except topical treated skin disease and respiratory disease)
- Current Immunosuppressive treatment
- Unable to participate in CAM-S measurement
- Peptic ulcera
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Hvidovre, department of anesthesiology
Hvidovre, 2650
About this study
Official title: Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.
The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery.
Read the detailed description
Patients with Hip Fracture are exposed for two traumas that can trigger a stress response. The first is the fall that causes the Fracture. The second is the surgery. In this study the intervention is dispensed early in the disease course - as soon as the Fracture has been diagnosed and booked for surgery.
- Conditions
- Delirium - Postoperative, Stress, Physiological
- Being tested
- methylprednisolone sodium succinate, placebo saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone sodium succinateDrug
Also called Solu-medrol Product Code 52245
Single dose Intravenous
placebo salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone sodium succinate | Active comparator | 125 mg iv, as single dose, preoperative. Receives: Drug: methylprednisolone sodium succinate |
| physiological saline | Placebo comparator | 5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi Receives: Drug: placebo saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Measured: 3 first post operative days
Secondary outcomes (7)
Post operative delirium incidents measured by CAM-S
Incidents of delirium measured by CAM-S
Measured: 3 days
Patient mobility measured by Cumulated Ambulation Score (CAS)
Physiotherapy
Measured: 3 first operative days
The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)
Biomarker
Measured: 4 days
Post operative Fatigue measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).
Measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).
Measured: 3 first postoperative days
Psychiatric medications (total amount/use of psychiatric medications)
The total amount/use of psychiatric medications for every patient during the first 3 postoperative days.
Measured: 3 post-OR days
Postoperative infections (numbers of patients with postoperative infections)
numbers of patients with postoperative infections
Measured: 21 days
Length of stay in hospital
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Clemmesen, Hvidovre University Hospital
- Investigators
- Christopher Clemmesen, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317601
- Sponsor's protocol ID
- 2014-002492-29
- Other IDs
- 2014-002492-29, 2014
- Status last verified
- Jul 2016
- First submitted
- 27 Nov 2014
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium.
- ClinicalTrials.gov ID
- NCT02317601
- Acronym / sponsor ID
- 2014-002492-29
- Conditions
- Delirium - Postoperative, Stress, Physiological
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery.
Detailed description
Patients with Hip Fracture are exposed for two traumas that can trigger a stress response. The first is the fall that causes the Fracture. The second is the surgery. In this study the intervention is dispensed early in the disease course - as soon as the Fracture has been diagnosed and booked for surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone sodium succinate | Active comparator | Drug: methylprednisolone sodium succinate125 mg iv, as single dose, preoperative. |
| physiological saline | Placebo comparator | Drug: placebo saline5 mL of Sodium-Chloride 9 mg/ml, Fresenius Kabi |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients undergoing surgery for hip fracture
- Informed signed consent
- Danish speaking
Key exclusion criteria (10 listed)
- Allergies towards contents of Solu-Medrol
- Insulin dependent diabetes
- Glaucoma
- In treatment for cancer disease
- Positive HIV, Hepatitis b or C status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisolone sodium succinateAlso: Solu-medrol Product Code 52245Single dose Intravenous | Drug | Methylprednisolone sodium succinate |
| placebo saline | Drug | physiological saline |
Primary outcome
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
Time frame: 3 first post operative days
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S
7 secondary outcomes
Post operative delirium incidents measured by CAM-S
Time frame: 3 days
Patient mobility measured by Cumulated Ambulation Score (CAS)
Time frame: 3 first operative days
The degree of inflammatory response measured by biomarker in the blood (suPAR, Interleukin 6, and others)
Time frame: 4 days
Post operative Fatigue measured with a patient fatigue self-assessment 0-4. (Verbal rating scale) 0=no fatigue, 1=mild, 2 = moderate, 3 = severe, 4 = excruciating (in bed because of fatigue).
Time frame: 3 first postoperative days
Psychiatric medications (total amount/use of psychiatric medications)
Time frame: 3 post-OR days
Postoperative infections (numbers of patients with postoperative infections)
Time frame: 21 days
Length of stay in hospital
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Clemmesen, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylprednisolone sodium succinate in people with Delirium - Postoperative and Stress, Physiological, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative delirium measured with Confusion Assessment Method severity measure CAM-S (time frame: 3 first post operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.