NCT05964088

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

July 24, 2023

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    mortality at hospital discharge

    from admission until death from any cause, whichever comes first, assessed up to three months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon admission to the hospital

You may not qualify if:

  • chronic kidney disease end stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael M Neeki, DO

    Arrowhead Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

July 24, 2023

First Posted

July 27, 2023

Study Start

March 1, 2020

Primary Completion

February 12, 2022

Study Completion

February 12, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations