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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

Tracking Information
First Submitted Date July 10, 2014
First Posted Date July 14, 2014
Last Update Posted Date July 12, 2017
Study Start Date June 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2014)
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 ]
Original Primary Outcome Measures
 (submitted: July 11, 2014)
Progression of serum procalcitonin levels [ Time Frame: up to 10 days ]
Assess the correlation between elevated serum procalcitonin levels and subsequent development of sepsis in patients previously treated with cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC).
Change History
Current Secondary Outcome Measures
 (submitted: November 26, 2014)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery
Official Title A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Collection of serum blood specimens
Sampling Method Non-Probability Sample
Study Population Cancer patients having undergone cytoreductive surgery with or without HIPEC
Condition 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.

Study Groups/Cohorts Cytoreductive surgery
Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws
Intervention: Other: Serum procalcitonin lab draws
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 11, 2014)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02189434
Other Study ID Numbers ERMC 14-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Eastern Regional Medical Center
Study Sponsor Eastern Regional Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Rod Flynn, MD Eastern Regional Medical Center
PRS Account Eastern Regional Medical Center
Verification Date July 2017