Detection of Immune Changes as a Result of Surgical Trauma in Human Subject

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01578798

Enrollment

Registered

2012-04-17

Start date

2012-03-31

Completion date

2013-07-31

Last updated

2013-10-30

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

Conditions

Surgical Trauma

Brief summary

Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study to characterize the cellular and molecular mechanisms immune response to surgical trauma. Additionally, detailed information about patients' recovery profile will be recorded over a period of 6 weeks, with the eventual goal of linking immune responses to recovery profiles.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* 18 - 90 * Planning to undergo hip surgery * Fluent in English * Willing and able to sign informed consent and HIPAA authorization

Exclusion criteria

* Any systemic disease that might compromise the immune system * Diagnosis of cancer within the last 5 years * Psychiatric, immunological, and neurological conditions that would interfere with the collection and interpretation of study data * Pregnancy * Any other conditions that, in the opinion of the investigators, may compromise a participant's safety or the integrity of the study

Design outcomes

Primary

Measure	Time frame	Description
Mass cytometry of immune signaling events	Blood samples for mass cytometry will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.	The primary molecular outcome is the fold change in phosphorylation of signaling proteins.

Secondary

Measure	Time frame	Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	Western Ontario and McMaster Universities Arthritis Index is a validated questionnaires yielding a numerical score and assessing functional status and pain in patients suffering from osteoarthritis of the hip.
Plasma cytokines	Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.	The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.
Surgical Recovery Scale (SRS)	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.

Countries

United States

Outcome results