Cytoreductive Surgery
Conditions
Brief summary
Serum procalcitonin levels will be considerably higher, for a longer period of time, in patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU methods.
Interventions
OTHERSerum procalcitonin lab draws
Blood will be collected in a 4mL capacity, green top lithium heparin tube. Samples can be drawn from a port with other labs. The samples will be centrifuged and then the plasma/serum will be removed and placed into a screw-capped round bottom plastic vial. Samples will be stored at -20○C until processing. Serum samples will be batch processed for each participant at the conclusion of their study period. These draws will be conducted for the sole purpose of this study, and whenever possible, they will be performed at the same time as routine blood draws conducted for medical monitoring to reduce the burden to the patients.
Sponsors
Eastern Regional Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female or male person ≥ 18 years of age * Biopsy proven carcinoma * Scheduled for cytoreductive surgery, with or without HIPEC * Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2 * Able to give informed consent for protocol participation
Exclusion criteria
* Participants are not able to understand or provide written informed consent * Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood draw * Pre-operative infection treatment with corticosteroids within 72 hours of their baseline blood draw * Immunosuppressive illness other than neoplasm * Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC. | end of study |
Secondary
| Measure | Time frame |
|---|---|
| Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC. | end of study |
Countries
United States
Outcome results
None listed