Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

Sponsor

Eastern Regional Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02189434

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytoreductive Surgery	Other: Serum procalcitonin lab draws

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cytoreductive surgery Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws	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.

Arm

Intervention/Treatment

Cytoreductive surgery

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

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern Regional Medical Center	Philadelphia	Pennsylvania	United States	19124

Sponsors and Collaborators

Eastern Regional Medical Center

Investigators

Principal Investigator: Rod Flynn, MD, Eastern Regional Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eastern Regional Medical Center

ClinicalTrials.gov Identifier:

NCT02189434

Other Study ID Numbers:

ERMC 14-14

First Posted:

Jul 14, 2014

Last Update Posted:

Jul 12, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Sepsis

Study Results

No Results Posted as of Jul 12, 2017