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Clinical Trials/NCT05348759
NCT05348759
Completed
Not Applicable

Follow-up Study of the Pulmonary Function and CT Scan Finding in Chronic Kidney Disease Patients After COVID-19 Infection

Bangkok Metropolitan Administration Medical College and Vajira Hospital1 site in 1 country100 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Enrollment
100
Locations
1
Primary Endpoint
Chest CT in ESRD patients after recovered from COVID-19
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) on dialysis. CKD requires particular emphasis during the pandemic due to concern for increased susceptibility to infection from greater use of health facilities in people undergoing maintenance hemodialysis. COVID-19 due to SARS-CoV-2 involves multiple organs and lung injury is one of the most clinical manifestations. The binding of SARS-CoV-2 to the ACE2 receptors at target cells ,including type II pneumocytes ,and alveolar macrophages in the lung could arise into acute systemic inflammatory responses and cytokine storm.The consequentially leading to lung-resident dentritic cells (rDCs) activation, T lymphocytes production and release antiviral cytokines into the alveolar septa and interstitial compartments resulting in diffuse alveolar epithelium destruction,hyaline membrane formation, alveolar septal fibrous proliferation and pulmonary fibrosis.Although it has been reported that subgroups of COVID-19 survivors developed persistent lung parenchymal injury that persisted at least after 6 months 5-6 ,the data in CKD patients has not been reported yet.In addition, a study of pulmonary function test after COVID-19 is needed to be investigated.Thus,we plan to assess pulmonary sequalae of COVID-19 in hemodialysis (HD) patients and pulmonary function test after recovered of infection at least 3 months.

Detailed Description

This is the prospective,observational cohort study including CKD stage 5 on hemodialysis who survived acute COVID-19 and presented for clinical follow-up after either mild/moderate or severe COVID-19.The study was conducted at Faculty of Medicine ,Vajira Hospital ,Navamindradhiraj University from June 2022 -September 2022.We adhered to the Declaration of Helsinki,and all patients provided written informed consent before inclusion.Ethics approval was obtained from Institutional Review Board (IRB) prior to start of the study (COA No 302/64 E).

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thananda Trakarnvanich

Associate Professor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Eligibility Criteria

Inclusion Criteria

  • CKD stage 5 requiring HD or continuous peritoneal dialysis (CAPD ) for more than 3 months
  • Age 18-80 years
  • Diagnosis of COVID-19 confirmed by real time polymerase chain reaction (RT-PCR) and recovered for more than3 months previously

Exclusion Criteria

  • patients with history of chronic lung diseases i.e chronic obstructive pulmonary disease (COPD) and restrictive lung disease.

Outcomes

Primary Outcomes

Chest CT in ESRD patients after recovered from COVID-19

Time Frame: 3 months

Chest CT scan

Pulmonary s function tests in ESRD patients after recovered from COVID-19

Time Frame: 3 months

Pulmonary function test

Secondary Outcomes

  • Factors affecting the pumonary sequalae after COVID-19 in CKD patients(3 months)

Study Sites (1)

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