Cytoreductive SurgeryNCT02189434
Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery
An observational study of Cytoreductive Surgery, run by Eastern Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytoreductive Surgery
- What is being tested?
- Serum procalcitonin lab draws
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients having undergone cytoreductive surgery with or without HIPEC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
Official title: A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery
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
- Being tested
- Serum procalcitonin lab draws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum procalcitonin lab drawsOther
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 group | Role | What they receive |
|---|---|---|
| Cytoreductive surgery | Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws Receives: Other: Serum procalcitonin lab draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytoreductive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rod Flynn, MD, Principal investigator, Eastern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189434
- Sponsor's protocol ID
- ERMC 14-14
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT02189434
- Acronym / sponsor ID
- ERMC 14-14
- Conditions
- Cytoreductive Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytoreductive surgery | – | Other: Serum procalcitonin lab drawsPatients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients having undergone cytoreductive surgery with or without HIPEC
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum procalcitonin lab drawsBlood 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. | Other | Cytoreductive surgery |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rod Flynn, MD principal investigator
Eastern Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytoreductive Surgery, run by Eastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.