Total Hip ReplacementNCT01782859
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
A study testing Prednisone and Hydrocortisone in people with Total Hip Replacement, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Prednisone and Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
- Patients between the age of 50 and 90
Who cannot join
- Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
- Patients who are smokers
- Patients who have diabetes
- Patients who are <50 and >90 years of age
- Patients with history of prior difficulties tolerating corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
- Conditions
- Total Hip Replacement
- Being tested
- Prednisone, Hydrocortisone, Placebo (for Prednisone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Low dose steroids to be administered preoperatively and then repeated over a 24-hour period, 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital, 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by, 3. Another dose of 100 mg hydrocortisone IV 8 hours after
HydrocortisoneDrug
Also called Low dose steroids to be administered preoperatively and then repeated over a 24-hour period, 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital, 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by, 3. Another dose of 100 mg hydrocortisone IV 8 hours after
Placebo (for Prednisone)Drug
Also called Lactose filler to mimic 20 mg prednisone tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control group Receives: Drug: Placebo (for Prednisone) |
| Prednisone/hydrocortisone | Active comparator | Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV Receives: Drug: Prednisone; Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Measured: First 24 hours after surgery
Plasmin-a 2 Antiplasmin Complex (PAP)
Measured: First 24 hours after surgery
Secondary outcomes (3)
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Measured: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Desmosine Level (Marker of Lung Injury)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Measured: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Pain at 3 Months Post-op
At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782859
- Sponsor's protocol ID
- 2012-008
- Status last verified
- Jul 2016
- First submitted
- 28 Jan 2013
- Last updated
- 5 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
- ClinicalTrials.gov ID
- NCT01782859
- Acronym / sponsor ID
- 2012-008
- Conditions
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 10 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo (for Prednisone)Control group |
| Prednisone/hydrocortisone | Active comparator | Drug: Prednisone, Drug: HydrocortisoneSteroid group will receive the following: 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
- Patients between the age of 50 and 90
Key exclusion criteria (5 listed)
- Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
- Patients who are smokers
- Patients who have diabetes
- Patients who are <50 and >90 years of age
- Patients with history of prior difficulties tolerating corticosteroids
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 |
|---|---|---|
| PrednisoneAlso: Low dose steroids to be administered preoperatively and then repeated over a 24-hour period, 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital, 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by, 3. Another dose of 100 mg hydrocortisone IV 8 hours after | Drug | Prednisone/hydrocortisone |
| HydrocortisoneAlso: Low dose steroids to be administered preoperatively and then repeated over a 24-hour period, 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital, 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by, 3. Another dose of 100 mg hydrocortisone IV 8 hours after | Drug | Prednisone/hydrocortisone |
| Placebo (for Prednisone)Also: Lactose filler to mimic 20 mg prednisone tablet | Drug | Placebo |
Primary outcome
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Time frame: First 24 hours after surgery
Plasmin-a 2 Antiplasmin Complex (PAP)
Time frame: First 24 hours after surgery
3 secondary outcomes
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
Time frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Desmosine Level (Marker of Lung Injury)
Time frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Pain at 3 Months Post-op
Time frame: 3 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone and Hydrocortisone in people with Total Hip Replacement, run by Hospital for Special Surgery, New York at 1 site in United States.
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 2 inclusion and 5 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 5 Jan 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Prothrombin Fragment 1 and 2 (PF 1.2) (time frame: First 24 hours after surgery). The study lists 2 primary outcomes in all. 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 5 Jan 2017.