Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

Completed

• Conditions: Cytoreductive Surgery
• Interventions: Other: Serum procalcitonin lab draws

• Registration Number: NCT02189434
• Lead Sponsor: Eastern Regional Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cytoreductive surgery	Serum procalcitonin lab draws	Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Eastern Regional Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States