Acute Kidney InjuryNCT05964088
Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
An observational study of Acute Kidney Injury, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 12 Feb 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital
Who cannot join
- chronic kidney disease end stage renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
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
- Conditions
- Acute Kidney Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mortality
mortality at hospital discharge
Measured: from admission until death from any cause, whichever comes first, assessed up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Mar 2020
- Primary completion12 Feb 2022
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Neeki, Arrowhead Regional Medical Center
- Investigators
- Michael M Neeki, DO, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964088
- Sponsor's protocol ID
- 22-18
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischer N, Miao X, Weck D, Matalon J, Neeki CC, Pennington T, Dong F, Arabian S, Neeki MM. Mortality and morbidity associated with new onset acute kidney injury in critically ill COVID-19 infection patients. Int J Emerg Med. 2024 Jul 29;17(1):97. doi: 10.1186/s12245-024-00666-6.
PubMed 39075369
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
- ClinicalTrials.gov ID
- NCT05964088
- Acronym / sponsor ID
- 22-18
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 27 Jul 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital
Key exclusion criteria (1 listed)
- chronic kidney disease end stage renal disease
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
Mortality
Time frame: from admission until death from any cause, whichever comes first, assessed up to three months
mortality at hospital discharge
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 27 Jul 2023.
- Derived from this study: PubMed 39075369Fischer N, Miao X, Weck D, Matalon J, Neeki CC, Pennington T, Dong F, Arabian S, Neeki MM. Mortality and morbidity associated with new onset acute kidney injury in critically ill COVID-19 infection patients. Int J Emerg Med. 2024 Jul 29;17(1):97. doi: 10.1186/s12245-024-00666-6.
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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.
Michael M Neeki, DO principal investigator
Arrowhead Regional Medical Center
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 Acute Kidney Injury, run by Arrowhead Regional Medical Center at 1 site in United States.
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 27 Jul 2023. 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 United States. 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?
Mortality (time frame: from admission until death from any cause, whichever comes first, assessed up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964088, which also lists 1 linked publication.
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 27 Jul 2023.