Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

Cytoreductive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189434
• Other study ID #: ERMC 14-14
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: July 10, 2017
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2017
• Source: Eastern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytoreductive Surgery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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