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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348759
• Other study ID #: 302/64E
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Lung Function Decreased
• Xray Complication

Intervention

Diagnostic Test:
• Pulmonary function 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
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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine ,Vajira hospital,Navamindradhiraj University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Chu H, Chan JF, Wang Y, Yuen TT, Chai Y, Hou Y, Shuai H, Yang D, Hu B, Huang X, Zhang X, Cai JP, Zhou J, Yuan S, Kok KH, To KK, Chan IH, Zhang AJ, Sit KY, Au WK, Yuen KY. Comparative Replication and Immune Activation Profiles of SARS-CoV-2 and SARS-CoV in Human Lungs: An Ex Vivo Study With Implications for the Pathogenesis of COVID-19. Clin Infect Dis. 2020 Sep 12;71(6):1400-1409. doi: 10.1093/cid/ciaa410. — View Citation

Gagliardi I, Patella G, Michael A, Serra R, Provenzano M, Andreucci M. COVID-19 and the Kidney: From Epidemiology to Clinical Practice. J Clin Med. 2020 Aug 4;9(8):2506. doi: 10.3390/jcm9082506. — View 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. — View Citation

Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247. — View Citation

Ooi GC, Khong PL, Muller NL, Yiu WC, Zhou LJ, Ho JC, Lam B, Nicolaou S, Tsang KW. Severe acute respiratory syndrome: temporal lung changes at thin-section CT in 30 patients. Radiology. 2004 Mar;230(3):836-44. doi: 10.1148/radiol.2303030853. — View Citation

Tharaux PL, Chatziantoniou C, Fakhouri F, Dussaule JC. Angiotensin II activates collagen I gene through a mechanism involving the MAP/ER kinase pathway. Hypertension. 2000 Sep;36(3):330-6. doi: 10.1161/01.hyp.36.3.330. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest CT in ESRD patients after recovered from COVID-19	Chest CT scan	3 months
Primary	Pulmonary s function tests in ESRD patients after recovered from COVID-19	Pulmonary function test	3 months
Secondary	Factors affecting the pumonary sequalae after COVID-19 in CKD patients	oxygen requirement	3 months
Secondary	Factors affecting the pumonary sequalae after COVID-19 in CKD patients	Ventilator needed	3 months
Secondary	Factors affecting the pumonary sequalae after COVID-19 in CKD patients	Interleukin-6 level	3 months
Secondary	Factors affecting the pumonary sequalae after COVID-19 in CKD patients	C-reactive protein level	3 months