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NCT Number: NCT05348759

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pulmonary Function Test

Diagnostic Test

Spirometry was performed by trained nurse at division of pulmonology, Vajira hospital. The forced vital capacity (FVC), forced expiratory volume in first second of exhalation (FEV1), forced mid-expiratory flow (FEF25-75%), and the FEV1/FVC ratio before and after bronchodilators (2 puffs of salbutamol via spacer) were collected in all cases. Total lung capacity (TLC) using the spirometry (Masterscreen PFT, Jaeger, Germany) and diffusion capacity of carbon monoxide was performed in selected case with abnormalities of lung parenchyma found from computed tomography of the chest.

Chest computer scan

Diagnostic Test

High-resolution computed tomography (HRCT) was performed in a single breath-hold on a 128 slice multidetector computed tomography (MDCT) scanner (Philips Healthcare Nederland B.V, Ingenuity 128, Netherlands). HRCT was performed with the patient in the supine position during end-inspiration, supine position during end-expiration, and prone position during end-inspiration with 1 millimeter (mm) slice thickness.

Primary outcomes

  1. Chest CT in ESRD patients after recovered from COVID-19

    Time frame: 3 months

    Chest CT scan

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

    Time frame: 3 months

    Pulmonary function test

Secondary outcomes

  1. Factors affecting the pumonary sequalae after COVID-19 in CKD patients

    Time frame: 3 months

    oxygen requirement

  2. Factors affecting the pumonary sequalae after COVID-19 in CKD patients

    Time frame: 3 months

    Ventilator needed

  3. Factors affecting the pumonary sequalae after COVID-19 in CKD patients

    Time frame: 3 months

    Interleukin-6 level

  4. Factors affecting the pumonary sequalae after COVID-19 in CKD patients

    Time frame: 3 months

    C-reactive protein level

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Feb 8, 2023

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.

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