Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience From the Middle East

NCT ID: NCT04542954

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-08-31

Brief Summary

Methods: Out of 2000 kidney transplant recipients in our center in Kuwait, collecting data was started for all COVID-19-positive kidney transplant recipients till August 2020. Clinical features, management details and both patient and graft outcomes were reported.

Detailed Description

Before COVID-19 pandemic, nearly 2000 kidney transplant recipients were followed in our center in Kuwait. Data collection of such infected cases were started after diagnosing the 1st case during 1st week of March 2020. An ongoing study was performed that included 8 governmental acute care hospitals in Kuwait. All COVID-19-positive adult kidney transplant recipients with a functioning allograft who presented to the emergency department and were either discharged or hospitalized between March 1, 2020 and August 1, 2020 were included. Clinical features, management details and both patient and graft outcomes were reported. Data were collected from the electronic health record reporting database of both the mother transplant center and isolation hospitals.

Laboratory diagnosis:

COVID-19 positivity was defined as a positive result on real-time polymerase chain reaction (PCR) assay of nasopharyngeal swab specimens targeting the RNA-dependent RNA polymerase gene using amplification according to manufacturer's recommendation. Kidney transplant status was defined as an active International Statistical Classification of Diseases and Related Health Problems 10 code of T86.1, T86.10, T86.11, T86.12, T86.13, T86.19, or Z94.0. All electronic files were manually reviewed for demographics, history of recent exposure, immunosuppression changes, clinical signs and symptoms suggesting COVID-19, and laboratory findings with special stress on serum creatinine, liver function tests, D dimer, procalcitonin (PCT), C reactive protein and complete blood count. Acute kidney injury was graded according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. AKI was staged for severity according to the following criteria: Stage 1 when creatinine was ranging between 1.5-<2 folds of basal; stage 2 if the creatinine was ranging between 2-<3folds and stage 3 if creatinine was more than 3 folds the basal. The study was approved by the ethical committee of ministry of health of Kuwait. Written informed consent was waived in light of the urgent need to collect data.

Radiological assessment:

The presence of a radiologic abnormality was determined 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 extracted the data. If a major disagreement between two reviewers happened it was resolved by consultation with a third reviewer. 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.7

Statistics:

Statistical analyses were conducted using SPSS version 20.0 (SPSS, Chicago, IL, USA). Qualitative data were presented as number and percent, and quantitative data were presented as means ± standard deviation and median. The t-test was used to compare means and standard deviations of the studied groups. Categorical data were compared using the chi-squared test. P values will be considered significant if < 0.05.

Conditions

Covid19; Kidney Transplant Infection; Risk Factor, Cardiovascular; Immunosuppression; Outcome, Fatal; Graft Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East

Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All renal transplant patients infected with COVID-19 during the period of 6 months from 3.2020 till the end of 8.2020

Exclusion Criteria

• Pediatric patients

• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Kuwait

OTHER_GOV

Sponsor Role: collaborator

Hamid Al-Essa Organ Transplant Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OTC, MOH , Kuwait

Kuwait City, , Kuwait

Countries

Kuwait

Other Identifiers

2020/1481

Identifier Type: -

Identifier Source: org_study_id