Acute Kidney InjuryNCT03097393
Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis
An observational study of Acute Kidney Injury, run by Benha University.
Trial summary
The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- measure Serum procalcitonin level
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 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: ICU patients with sepsis
Who may be able to join
- ICU patients with sepsis
Who cannot join
- Patient known to have End-stage kidney disease
- Patients on Renal replacement therapy
- patients without procalcitonin level within 24 hours from admission.
About this study
The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.
Read the detailed description
67 patients with sepsis were enrolled in this study. On admission, PCT was measured together with serum creatinine, urea, and other inflammatory markers. Quick Sepsis-related Organ Failure Assessment was calculated at the emergency department. Patients were classified into those with Acute kidney injury (AKI) and non-AKI groups.
- Conditions
- Acute Kidney Injury
- Being tested
- measure Serum procalcitonin level
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure Serum procalcitonin levelDiagnostic test
measuring procalcitonin level
| Study group | Role | What they receive |
|---|---|---|
| AKI GROUP | measure Procalcitonin among Patient developed Acute kidney injury during ICU stay Receives: Diagnostic Test: measure Serum procalcitonin level | |
| Non-AKI group | measure Procalcitonin among Patient did not develop Acute kidney injury during ICU stay Receives: Diagnostic Test: measure Serum procalcitonin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of AKI
elevated kidney functions creatinine or oliguria
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jan 2014
- 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 Acute Kidney InjuryStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097393
- Sponsor's protocol ID
- Benha317
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis
- ClinicalTrials.gov ID
- NCT03097393
- Acronym / sponsor ID
- Benha317
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 31 Mar 2017 (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 aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.
Detailed description
67 patients with sepsis were enrolled in this study. On admission, PCT was measured together with serum creatinine, urea, and other inflammatory markers. Quick Sepsis-related Organ Failure Assessment was calculated at the emergency department. Patients were classified into those with Acute kidney injury (AKI) and non-AKI groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI GROUP | – | Diagnostic Test: measure Serum procalcitonin levelmeasure Procalcitonin among Patient developed Acute kidney injury during ICU stay |
| Non-AKI group | – | Diagnostic Test: measure Serum procalcitonin levelmeasure Procalcitonin among Patient did not develop Acute kidney injury during ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with sepsis
Key inclusion criteria (1 listed)
- ICU patients with sepsis
Key exclusion criteria (3 listed)
- Patient known to have End-stage kidney disease
- Patients on Renal replacement therapy
- patients without procalcitonin level within 24 hours from admission.
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 |
|---|---|---|
| measure Serum procalcitonin levelmeasuring procalcitonin level | Diagnostic test | AKI GROUP, Non-AKI group |
Primary outcome
development of AKI
Time frame: 28 Days
elevated kidney functions creatinine or oliguria
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 31 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Benha University.
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 3 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
development of AKI (time frame: 28 Days). 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 31 Mar 2017.