Pulmonary Function and CT Scan Finding in CKD Patients After COVID-19 Infection

Completed

• Conditions: COVID-19; Lung Function Decreased; Xray Complication

• Registration Number: NCT05348759
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

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).

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-27
• Study Start: 2022-07-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chest CT in ESRD patients after recovered from COVID-19	3 months	Chest CT scan
Pulmonary s function tests in ESRD patients after recovered from COVID-19	3 months	Pulmonary function test

Secondary Outcome Measures

Name	Time	Method
Factors affecting the pumonary sequalae after COVID-19 in CKD patients	3 months	C-reactive protein level

Trial Locations

Locations (1)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University; 🇹🇭 Bangkok, Thailand