- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03097393
Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis
March 25, 2017 updated by: Mahmoud Hamada imam, Benha University
The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
67
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ICU patients with sepsis
Description
Inclusion Criteria:
- ICU patients with sepsis
Exclusion Criteria:
- Patient known to have End-stage kidney disease
- Patients on Renal replacement therapy
- patients without procalcitonin level within 24 hours from admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AKI GROUP
measure Procalcitonin among Patient developed Acute kidney injury during ICU stay
|
measuring procalcitonin level
|
|
Non-AKI group
measure Procalcitonin among Patient did not develop Acute kidney injury during ICU stay
|
measuring procalcitonin level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
development of AKI
Time Frame: 28 Days
|
elevated kidney functions creatinine or oliguria
|
28 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
March 25, 2017
First Submitted That Met QC Criteria
March 25, 2017
First Posted (Actual)
March 31, 2017
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 25, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Benha317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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