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Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

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ClinicalTrials.gov Identifier: NCT02189434
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cytoreductive Surgery Other: Serum procalcitonin lab draws

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 : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort 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.





Primary Outcome Measures :
  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. [ Time Frame: end of study ]

Secondary Outcome Measures :
  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. [ Time Frame: end of study ]

Biospecimen Retention:   Samples With DNA
Collection of serum blood specimens


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients having undergone cytoreductive surgery with or without HIPEC
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189434


Locations
United States, Pennsylvania
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

Responsible Party: Eastern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02189434     History of Changes
Other Study ID Numbers: ERMC 14-14
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs