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CompletedNCT04979195AKI-COVID-19Updated Jul 28, 2021

Acute Kidney Injury Among COVID-19 Positive Patients

An observational study in COVID-19 Positive Patients With Acute Kidney Injury, sponsored by Hamid Al-Essa Organ Transplant Center. Completed at 2 sites in Kuwait. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Hamid Al-Essa Organ Transplant Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
649
Ages
21 Years to 90 Years
Sex
All
01

Study summary

In Kuwait, the total number of COVID-19 confirmed cases exceeds 5000 patients. Risk factors of possible risk factors of confirmed COVID-19 infection that developed major organ dysfunction are not yet identified among patients in Kuwait.

we aimed to describe the clinical characteristics of hospitalized symptomatic COVID-19 positive patients, assess possible risk factors of confirmed COVID-19 infection who developed major organ dysfunction, determine risk factors for renal dysfunction and their outcome and assess the response of critically ill patients to different therapeutic modalities.

Read the detailed description

In this observational study, we will revise all medical records of hospitalized patients with laboratory-confirmed Covid-19, during the period between Feb till July 2020. A confirmed case of Covid-19 is defined as a positive result on high throughput sequencing or real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens.12 We will include only laboratory-confirmed cases in the analysis.

We will extract patients' data with special stress on socio-demographic data, associated medical co-morbidities as diabetes, hypertension, ischemic heart disease, chronic lung disease, recent exposure history, clinical symptoms or signs of the upper and lower respiratory system, and laboratory findings on admission. Radiologic assessments will be included like chest radiography or computed tomography (CT), and all laboratory testing will be performed according to the clinical care needs of the patient.

We will determine the presence of a radiologic abnormality on the basis of the documentation or description in medical charts of infected patients; if imaging scans were available, they were reviewed by attending physicians in respiratory medicine who will extract the data. If a major disagreement between two reviewers happens it will be resolved by consultation with a third reviewer. Laboratory assessments will include a complete blood count, blood chemical analysis, coagulation testing, assessment of liver and renal function, and measures of electrolytes, C-reactive protein, procalcitonin, lactate dehydrogenase, creatine kinase, ferritin, D dimer, and troponin. The degree of severity of Covid-19 (severe vs. non-severe) at the time of admission will be defined using the American Thoracic Society guidelines for community-acquired pneumonia.

Data will be entered into a computerized database SPSS program file and cross-checked. If the core data are missing, requests for clarification will be sent to the coordinators, who subsequently will contact the attending clinicians.

Treatment and Complications:

We will report patients who are receiving antibiotics, antiviral (different regimens), those who required oxygen therapy (invasive, non-invasive ventilation or extracorporeal membrane oxygenation, (ECMO)), and those patients who received systemic steroid therapy. Moreover, the duration of hospitalization will be reported. Also, patients who developed acute kidney injury will be recorded and if they were dialyzed, all dialysis parameters will be recorded including any associated complications. All mortality patients will be reported with special stress on the cause of death.

02

Conditions studied

  • COVID-19 Positive Patients With Acute Kidney Injury
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 649 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hamid Al-Essa Organ Transplant Center is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

649 COVID-19 positive patients were identified. Sixty-three were isolated at home and 586 cases needed hospital admission during the period between the 1st week of March till the end of August 2020. Among the hospitalized cases, 258 needed ICU care while 328 were managed in the COVID general wards. We compared patients with stable renal function (group 1, n=319) vs. those who developed AKI (group 2, n=267).

We collected the data from COVID-19 positive patients that were diagnosed in all government hospitals in Kuwait. Clinical features, details of management, and both patient and renal outcomes were recorded. We compiled patients' data from the electronic database of the isolation hospitals where COVID -19 cases were managed. Approval for the study was obtained from the ethical committee of the Kuwait Ministry of Health.

Inclusion criteria

  • All adult patients were included.
  • Hospitalized with PCR confirmed COVID-19 infection.
  • period between March to August 2020.

Exclusion criteria

Exclusion Criteria:

  • Pediatric patients Home isolated patients
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
649 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • Group 1

    patients with stable renal function.

    Other: Patients with stable normal kidney function · Other: Patients with unstable kidney function

  • Group 2

    Patients who developed AKI.

    Other: Patients with stable normal kidney function · Other: Patients with unstable kidney function

Interventions

  • OtherPatients with stable normal kidney function

    Covid-19 patients with stable kidney function will represent group 1.

    Also known as: Covid-19 patients with stable kidney fucntion.

  • OtherPatients with unstable kidney function

    Covid-19 patients with unstable kidney function will represent group 2.

    Also known as: Covid-19 patients with unstable kidney fucntion.

06

What researchers measure

Primary outcomes

  1. patient survival

    Patients who survived after 30 days.

    Time frame: 30 days

  2. Kidney survival

    Patients who have stable basal kidney function.

    Time frame: 30 days

07

Study locations

2 sites
  • Osama Gheith
    Kuwait, AZ 23424, Kuwait
  • Osama Gheith
    Kuwait, Rf Kuwait, Kuwait
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04979195
Lead sponsor
Hamid Al-Essa Organ Transplant Center
Responsible party
Sponsor
First posted
Jul 28, 2021
Start date
Mar 1, 2020
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Jul 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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