Hemodialysis Catheter InfectionNCT03039777
Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
An observational study of Hemodialysis Catheter Infection, run by Benha University at 1 site in Saudi Arabia.
Trial summary
Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter Infection
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2016to 1 Mar 2017
- 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: Hemodialysis patients with clinical signs of CRBSI
Who may be able to join
- Hemodialysis patients with a dialysis catheter
- signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection.
- Informed consent signed to be enrolled in the study
Who cannot join
- Patient with identified cause of fever other than CRBSI
Trial locations and contacts
1 site in 1 country.
About this study
Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI.
Read the detailed description
Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for CRBSI before blood culture results became available.
Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI by blood cultures.
- Conditions
- Hemodialysis Catheter Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin Level
Level of serum procalcitonin
Measured: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Sep 2016
- Primary completion28 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Catheter InfectionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
- Investigators
- Mahmoud H Imam, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039777
- Sponsor's protocol ID
- 17a1b
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03039777
- Acronym / sponsor ID
- 17a1b
- Conditions
- Hemodialysis Catheter Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 1 Feb 2017 (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.
Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI.
Detailed description
Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for CRBSI before blood culture results became available.
Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI by blood cultures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with clinical signs of CRBSI
Key inclusion criteria (3 listed)
- Hemodialysis patients with a dialysis catheter
- signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection.
- Informed consent signed to be enrolled in the study
Key exclusion criteria (1 listed)
- Patient with identified cause of fever other than CRBSI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procalcitonin Level
Time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
Level of serum procalcitonin
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 17 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis Catheter Infection
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Recruiting
Prophylactic Antibiotic Treatment in Hemodialysis
Hemodialysis
Not yet recruiting
Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
Haemodialysis, Haemodialysis Complication
Not yet recruiting
Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
Vascular Access Complication, Device Related Infection
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.
Mahmoud H Imam, MD principal investigator
Benha University
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 Hemodialysis Catheter Infection, run by Benha University at 1 site in Saudi Arabia.
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 3 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 17 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 Saudi Arabia. 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?
Procalcitonin Level (time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI). 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 17 Jul 2017.