Acute Kidney Injury Among COVID-19 Positive Patients

NCT ID: NCT04979195

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 649 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-08-31

Brief 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.

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.

Conditions

COVID-19 Positive Patients With Acute Kidney Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

patients with stable renal function.

Patients with stable normal kidney function

Intervention Type: OTHER

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

Patients with unstable kidney function

Intervention Type: OTHER

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

Group 2

Patients who developed AKI.

Patients with stable normal kidney function

Intervention Type: OTHER

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

Patients with unstable kidney function

Intervention Type: OTHER

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

Interventions

Patients with stable normal kidney function

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

Intervention Type: OTHER

Patients with unstable kidney function

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

Intervention Type: OTHER

Other Intervention Names

Covid-19 patients with stable kidney fucntion.; Covid-19 patients with unstable kidney fucntion.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pediatric patients Home isolated patients

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamid Al-Essa Organ Transplant Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Osama Gheith

Kuwait City, AZ, Kuwait

Osama Gheith

Kuwait City, Rf, Kuwait

Countries

Kuwait

Other Identifiers

2020/1467

Identifier Type: -

Identifier Source: org_study_id