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NCT01399268 · ClinicalTrials.gov registry record · Phase 4
Steroids in Bilateral Total Knee Replacement
A Phase 4 study of Postoperative Inflammatory Response, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01399268: Completed Phase 4 study of Postoperative Inflammatory Response, sponsored by Hospital for Special Surgery, New York.
NCT01399268 is a Phase 4 study of Postoperative Inflammatory Response that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01399268, a Phase 4 study of Postoperative Inflammatory Response, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours. Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury. Therefore the investigators hypothesize: Continued low dose steroids given three times over a 24 hour period will: 1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours. 2. Decrease urinary desmosine levels, and hence be protective of lung injury.
Conditions Studied
Interventions
- DRUG Saline
- DRUG Hydrocortisone
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-02 |
| Phase | Phase 4 |
What the finished NCT01399268 record still lists
NCT01399268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Postoperative Inflammatory Response appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT01399268 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01399268 about?
NCT01399268 is a clinical study titled "Steroids in Bilateral Total Knee Replacement". Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status...
What is the current status of trial NCT01399268?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2009-02. Estimated completion is 2011-02.
What conditions does trial NCT01399268 study?
This clinical trial studies the following conditions: Postoperative Inflammatory Response.
What interventions are being tested in trial NCT01399268?
The interventions under investigation include: Saline (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT01399268?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01399268 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01399268's enrollment target sits among peer trials
30 1552nd of 2000 higher than 368 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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