- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964088
Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
July 25, 2023 updated by: Michael Neeki, Arrowhead Regional Medical Center
This study explored the incidence of morbidity and mortality associated with AKI in critically ill adult patients infected with COVID-19.
There are two groups for comparison.
Group1.
patients were directly admitted to the intensive care unit (ICU) from the emergency department (ED) Group 2. patients were initially managed on the medical floor and later transferred to the ICU for worsening respiratory status.
The investigating team evaluated the correlation of inflammatory markers and common risk factors such as obesity, diabetes, hypertension and ethnicity to the development of AKI in the target population.
The primary outcome is mortality participants will received their regular healthcare in a medical setting
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
267
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Colton, California, United States, 92324
- Arrowhead Regional Medical Center
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This is a two-year retrospective study of critically ill adult patients infected with COVID-19 that were admitted to the intensive care unit on ventilatory support.
Patients included in this study were admitted to Arrowhead Regional Medical Center (ARMC) from March 1, 2020 to February 12, 2022.
Description
Inclusion Criteria:
positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital
Exclusion Criteria:
chronic kidney disease end stage renal disease
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Group1
These critically ill patients were directly admitted to the intensive care unit from the emergency department
|
|
Group 2
These critically ill patients were were initially managed on the medical floor and later transferred to the intensive care unit for worsening respiratory status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: from admission until death from any cause, whichever comes first, assessed up to three months
|
mortality at hospital discharge
|
from admission until death from any cause, whichever comes first, assessed up to three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael M Neeki, DO, Arrowhead Regional Medical Center
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)
March 1, 2020
Primary Completion (Actual)
February 12, 2022
Study Completion (Actual)
February 12, 2022
Study Registration Dates
First Submitted
July 24, 2023
First Submitted That Met QC Criteria
July 25, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-18
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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