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Completed

NCT Number: NCT04979195

Acute Kidney Injury Among COVID-19 Positive Patients

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Osama Gheith, Kuwait City, AZ, Kuwait

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients with stable normal kidney function

Other

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

Other names: Covid-19 patients with stable kidney fucntion.

Patients with unstable kidney function

Other

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

Other names: Covid-19 patients with unstable kidney fucntion.

Primary outcomes

  1. patient survival

    Time frame: 30 days

    Patients who survived after 30 days.

  2. Kidney survival

    Time frame: 30 days

    Patients who have stable basal kidney function.

Sponsors and collaborators

Lead sponsor

Hamid Al-Essa Organ Transplant Center

Other Gov

Registry information

Official study title

Acute Kidney Injury Among COVID-19 Positive Patients is Associated With Higher Mortality: a Single-center Experience

Acronym: AKI-COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.