Liver Transplant InfectionNCT03389360
Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant
An observational study of Liver Transplant Infection, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant Infection
- What is being tested?
- procalcitonin
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2018to 10 Feb 2019
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx)
Who may be able to join
- including adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx) at the Department of Liver Transplant of National Hepatology \& Tropical Medicine Research Institute (NHTMRI), between January 2014 and January 2018 \& with no contraindications for early immunosuppression.
Who cannot join
- Patients will be excluded from the study if they are readmitted or had primary graft nonfunction.
Trial locations and contacts
1 site in 1 country.
About this study
, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
Read the detailed description
All patients transferred from operative theatre to ICU will be sedated, intubated \& ventilated. They will receive empiric antimicrobial prophylaxis upon admission \& early immunosuppression according to the clinical practice guidelines in our center, (Appendix 1).
Preoperative patients' demographic data will be obtained. Model for end-stage liver disease (MELD) prior transplant, the primary cause of liver transplant.
Operative \& anesthetic details; operation time, units of blood, blood products transfusion, ischemic time, type of preservatives used, back table procedures, extra-hepatic procedure \& graft to recipient weight ratio will be recorded.
Postoperative patient evaluation will include; Sequential Organ Failure Assessment (SOFA) on admission \& /48h. Hemodynamic monitoring will include hourly measurement of heart rate, mean arterial pressure (MAP), temperature, central venous pressure (CVP), arterial oxygen saturation (SaO2), daily total volume of fluid infused, urine output, fluid balance daily, blood gases / 6h \& daily mean values will be recorded till hospital discharge.
Routine laboratory workup includes biochemical markers of liver, kidney function and hematological parameters (complete blood count \& coagulation profile).
Patient evaluation for infection will be done through scheduled measurements of PCT every other day during ICU stay \& upon needed during the hospital stay. Other markers of infections will be measured till hospital discharge as C-reactive protein (CRP) every other day, daily total leukocyte count (TLC) \& band cells %.
Microbiological evidence of infection will be confirmed by cultures that will be regularly sampled every other day during ICU stay \& upon any clinical or laboratory biomarker suggestive of infection.
Management of suspected infection; when PCT value rising with clinical, radiological \&/or laboratory evidence of infection (TLC, CRP, band%), culture from suspected site of infection will be withdrawn. If the source of infection is not evident, cultures from; blood, urine, sputum, surgical wound, drain \& nasal swab will be withdrawn \& empiric antimicrobial against gram +ve bacteria will be initiated. While the management of proven infection will be culture based antimicrobial initiation.
- Conditions
- Liver Transplant Infection
- Being tested
- procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitoninDiagnostic test
assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
value of procalcitonin to diagnose infection in early post liver transplant period
Measured: average two weeks during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start15 Mar 2018
- Primary completion20 Dec 2018
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant InfectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389360
- Sponsor's protocol ID
- NHTMRI
- Status last verified
- Mar 2021
- First submitted
- 25 Dec 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant
- ClinicalTrials.gov ID
- NCT03389360
- Acronym / sponsor ID
- NHTMRI
- Conditions
- Liver Transplant Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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.
, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
Detailed description
All patients transferred from operative theatre to ICU will be sedated, intubated \& ventilated. They will receive empiric antimicrobial prophylaxis upon admission \& early immunosuppression according to the clinical practice guidelines in our center, (Appendix 1).
Preoperative patients' demographic data will be obtained. Model for end-stage liver disease (MELD) prior transplant, the primary cause of liver transplant.
Operative \& anesthetic details; operation time, units of blood, blood products transfusion, ischemic time, type of preservatives used, back table procedures, extra-hepatic procedure \& graft to recipient weight ratio will be recorded.
Postoperative patient evaluation will include; Sequential Organ Failure Assessment (SOFA) on admission \& /48h. Hemodynamic monitoring will include hourly measurement of heart rate, mean arterial pressure (MAP), temperature, central venous pressure (CVP), arterial oxygen saturation (SaO2), daily total volume of fluid infused, urine output, fluid balance daily, blood gases / 6h \& daily mean values will be recorded till hospital discharge.
Routine laboratory workup includes biochemical markers of liver, kidney function and hematological parameters (complete blood count \& coagulation profile).
Patient evaluation for infection will be done through scheduled measurements of PCT every other day during ICU stay \& upon needed during the hospital stay. Other markers of infections will be measured till hospital discharge as C-reactive protein (CRP) every other day, daily total leukocyte count (TLC) \& band cells %.
Microbiological evidence of infection will be confirmed by cultures that will be regularly sampled every other day during ICU stay \& upon any clinical or laboratory biomarker suggestive of infection.
Management of suspected infection; when PCT value rising with clinical, radiological \&/or laboratory evidence of infection (TLC, CRP, band%), culture from suspected site of infection will be withdrawn. If the source of infection is not evident, cultures from; blood, urine, sputum, surgical wound, drain \& nasal swab will be withdrawn \& empiric antimicrobial against gram +ve bacteria will be initiated. While the management of proven infection will be culture based antimicrobial initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx)
Key inclusion criteria (1 listed)
- including adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx) at the Department of Liver Transplant of National Hepatology \& Tropical Medicine Research Institute (NHTMRI), between January 2014 and January 2018 \& with no contraindications for early immunosuppression.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they are readmitted or had primary graft nonfunction.
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 |
|---|---|---|
| procalcitoninassessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx. | Diagnostic test | – |
Primary outcome
frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
Time frame: average two weeks during hospital stay
value of procalcitonin to diagnose infection in early post liver transplant period
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 19 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplant Infection, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 inclusion and 1 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 19 Mar 2021. 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 Egypt. 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?
frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx. (time frame: average two weeks during hospital stay). 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 19 Mar 2021.