NCT04874779

Brief Summary

Background. Within a year, COVID-19 has advanced from being an outbreak to a pandemic, spreading rapidly and globally with devastating impact. Currently, there is an ongoing debate among scientists about the pathophysiological relationship between COVID-19 and acute kidney injury (AKI). While a few studies have concluded that the mechanisms of AKI in COVID-19 patients are seemingly multifactorial and have not been fully explicated, others asserted that AKI remains rare among COVID-19-related diseases. Considering this knowledge-gap and its potential impact on the management of COVID-19-associated AKI, our study aims to explore the prevalence of AKI and to identify possible risk factors associated with AKI development among COVID-19 hospitalized patients. Materials and Methods. This retrospective cohort study included 83 patients with COVID-19 hospitalized at AL-AHRAR Hospital, Zagazig, Egypt, between June and August,2020. Exclusion criteria were: patients younger than 18 years of age; diagnosed with end stage kidney disease; placed on maintenance dialysis; booked for a kidney transplant or on nephrotoxic medications. All patients included in the study underwent complete blood count; liver and renal function tests; examination of hemostasis parameters; inflammatory markers; serum electrolytes; routine urinalysis; arterial blood gas and non-enhanced chest and abdominal computer tomography (CT) scans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

July 23, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 2, 2021

Last Update Submit

July 16, 2021

Conditions

Keywords

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • The development of acute kidney injury or not following COVID-19

    2 months after enrollement

Study Arms (2)

Acute kidney injury (AKI) group

Acute kidney injury (AKI) group met the guidelines of Kidney Disease, Improving Global Outcomes (KDIGO)

Other: non

NON-Acute kidney injury (non-AKI) group

NON-Acute kidney injury (non-AKI) group not met the guidelines of Kidney Disease Improving Global Outcomes (KDIGO)

Other: non

Interventions

nonOTHER

follow up investigations

Acute kidney injury (AKI) groupNON-Acute kidney injury (non-AKI) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients' medical history, underlying diseases, medications administered at home and in hospital, laboratory data, non-enhanced chest and abdominal computer tomography (CT) scans, were retrieved from electronic medical records. According to the Ministry of Health and Population (MOHP), Egypt Management protocol for COVID-19 Patients, version 1.4, 30th May,2020, (10), all patients received standard of care treatment including: (a) oxygen supply to achieve SaO2 ≥ 90%; (b) Hydroxychloroquine (400 mg twice in first day then 200 mg twice for 6 days); (C) Vitamin C (1gm daily); (d) Zinc (50mg daily); (e) Acetylcysteine 200 mg t.d.s.; (f) lactoferrin one sachet twice daily; (g) Anticoagulation if D-dimer \> 1000.

You may qualify if:

  • According to the WHO guidelines, a confirmed diagnosis of COVID-19 was defined as a positive result of a quantitative real-time reverse-transcriptase-polymerase chain reaction (RT-PCR) detection in a nasopharyngeal swab.

You may not qualify if:

  • patients younger than 18 years, patients diagnosed with chronic kidney disease before admission, patients on maintenance dialysis or awaiting renal transplantation and patients taking any nephrotoxic medications a week prior to admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine -Zagazig University

Zagazig, Egypt

Location

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

  • mohamed ghonim

    Associate professor of Internal Medicine , faculty of medicine, Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor - Associate Professor of Internal Medicine- Faculty of Medicine

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 6, 2021

Study Start

June 8, 2020

Primary Completion

November 18, 2020

Study Completion

May 1, 2021

Last Updated

July 23, 2021

Record last verified: 2021-05

Locations