Clinical trial NCT05348759: Pulmonary Function and CT Scan Finding in CKD Patients After COVID-19 Infection
Official title: Follow-up Study of the Pulmonary Function and CT Scan Finding in Chronic Kidney Disease Patients After COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lung Function Decreased
Xray Complication
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2022-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 end stage renal disease patients requirung renal replacement therapy with history of COVID-19 admitted to Faculty of Medicine, Vajira hospital,Navamindradhiraj University

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).

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.

Primary outcomes:
measure: Chest CT in ESRD patients after recovered from COVID-19
timeFrame: 3 months
measure: Pulmonary s function tests in ESRD patients after recovered from COVID-19
timeFrame: 3 months
Secondary outcomes:
measure: Factors affecting the pumonary sequalae after COVID-19 in CKD patients
timeFrame: 3 months
measure: Factors affecting the pumonary sequalae after COVID-19 in CKD patients
timeFrame: 3 months
measure: Factors affecting the pumonary sequalae after COVID-19 in CKD patients
timeFrame: 3 months
measure: Factors affecting the pumonary sequalae after COVID-19 in CKD patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Study officials:
References:
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citation: Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.