Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

NCT02189434 | Completed

• 1 other identifier: ERMC 14-14
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytoreductive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Cytoreductive surgery

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

Other: Serum procalcitonin lab draws

Interventions

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.

Cytoreductive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients having undergone cytoreductive surgery with or without HIPEC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Regional Medical Center: lead

Study Sites (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of serum blood specimens

Study Officials

• Rod Flynn, MD

  Eastern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

US (1)