Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cytoreductive Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cytoreductive surgery

Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws

Serum procalcitonin lab draws

Intervention Type OTHER

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.

Interventions

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Serum 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No