Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

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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Key information

Conditions

Cytoreductive Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum procalcitonin lab draws

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.

Primary outcomes

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.

Time frame: end of study

Secondary outcomes

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.

Time frame: end of study

Sponsors and collaborators

Lead sponsor

Eastern Regional Medical Center

Other

Registry information

Official study title

A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 14, 2014
Registry last updated: Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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