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.
Objectives:
Primary objectives:
- To study the Chest CT and pulmonary function tests in
ESRD patients after recovered from COVID-19
Secondary objectives
- To study the factors affecting the
pulmonary sequalae after COVID-19 in CKD patients such as oxygen requirement,ventilator need and levels of
inflammatory cytokines such as
interleukin-6 (IL-6) and C-reactive protein (CRP)
6. Study
design
6.1 Type of study
Prospective
observational cohort study
6.2 Inclusion,exclusion and criteria to terminate the study
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
Criteria to withdraw from the protocol
-
Patients
who have active disease after enrollment
7. Sample size calculation
This study aimed to identify the
prevalence of pulmonary abnormalities in both radiographic findings and PFT
results after recovery from COVID-19 infection. We used the
following equation for estimating an infinite population proportion:
where,
n is the sample size
Zα/2is
the area
under the normal curve
The significance level for the
hypothesis was set to α = 0.05; thus Zα/2 = 1.96
d is the acceptable error (d = 0.10)
pis the prevalence
of lung abnormality, defined as p = 0.50, that yielded the maximum sample size;
thus,
n = 1.962 x 0.50 (1 - 0.50)
0.102
n = 97
We
recruited 100 cases by convenience sampling from a population of end-stage
kidney disease (ESKD) patients who had recovered from
COVID-19 infection.
8. Methodology:
1. After written inform
consent is obtained, we then collect demographic data and
information regarding disease history, coexisting medical conditions,
medication history, treatment during COVID-19 infection, including oxygen
requirement, and laboratory data (complete blood count [CBC] and measurement of
interleukin-6 [IL-6] and C-reactive protein [CRP] levels).
2. At least 3 months post COVID-19
infection, all patients will be evaluated for ongoing respiratory symptoms and
undergo PFT and chest CT scans as followed:
Computed tomography technique
High-resolution computed tomography (HRCT) was
performed in a single breath-hold on a 128-slice multidetector computed
tomography (MDCT) scanner (Ingenuity 128; Philips Healthcare Nederland B.V,
Netherlands). HRCT was performed with a 1-mm slice thickness with the patient
in the supine position during end-inspiration and prone position during
end-inspiration.
Computed tomography interpretation
Using a Picture Archiving and Communication
System (PACS; EV Insite version 3.11.1.500; PSP Corporation, Japan), three
radiologists with 9, 10, and 14 years of experience performed consensus
interpretations blinded to the patients’ clinical information. The readers
assessed the presence of the following CT patterns; consolidation, ground-glass
opacities (focal, multifocal, diffuse), mosaic attenuation patterns
(hypoattenuating and hyperattenuating areas), perilobular consolidation
(organizing pneumonia-like pattern), reticulations, architectural distortion,
honeycombing, traction bronchiectasis, pneumatocele, curvilinear lines,
nodules, and pleural thickening or pleural effusion.16 Additional
findings were annotated separately. The distribution of the patterns was
recorded as the upper lobe, middle lobe/lingual, or lower lobe. CT scores
reflecting the extent of lobar involvement were obtained using a five-point
scale (0: 0%, 1: <5%, 2: 5%-25%, 3: 26%-50%, 4: 51%-75%, 5: >75%; range,
0-5; global score, 0-25).
.
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: July 05, 2023
Last Modified: July 06, 2023
Protocol Integer ID: 84501
Funders Acknowledgement:
Navamindradhiraj University
Grant ID: 018/2566
Disclaimer
The authors declare no competing interests
Abstract
Primary
objectives:
-To study the Chest CT and
pulmonary function tests in ESRD patients after recovered from COVID-19
Secondary objectives
- To study the factors affecting the
pulmonary sequalae after COVID-19 in CKD patientssuch as oxygen requirement,ventilator need and levels of inflammatory
cytokines such as interleukin-6 (IL-6)
and C-reactive protein (CRP)
Type of study: Prospective observational cohort study
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
Criteria to withdraw from the protocol Patients who have active disease after enrollment
Participants 100 patients
Place- Faculty of Medicine,Vajira Hospital ,Navamindradhiraj University
The study was conducted according to the Declaration of Helsinki and Good Clinical
Practice guidelines, and all study methods were carried out in accordance with
relevant guidelines and regulations. All patients participating in the study
signed an informed consent before enrollment.
14. Expected outcomes of the study
This trial contribute to new knowledge, including the
consequences of the most affected organ (lung) after COVID-19, which has rarely
been reported previously. In addition, the factors that associated with poor
pulmonary outcome will also be considered.
15. Dissemination of results and publication policy
The
data supporting the findings of this study are available from the corresponding
author.
Safety warnings
Safety
considerations
The participants will have minimal effects from the
measurements performed in this study.The anticipated side effects from radiation
or pulmonary function testss will be closely monitored
Ethics statement
This trial was prospective registered at ClinicalTrials.Gov Identifier: NCT05348759
on 26/04/2022 and was approved by the institutional review board of the Faculty of
Medicine,Vajira Hospital,Navamindradhiraj University,Bangkok,Thailand (COA 302/64)
Follow-up Study of the Pulmonary Function and CT
scan finding in Chronic Kidney Disease Patients After COVID-19 Infection
Protocol references
1.
Syed-Ahmed M, Narayanan M. Immune dysfunction and risk of infection in chronic
kidney disease. Adv Chronic Kidney Dis. 2019 Jan;26(1):8–15.
2. Singh AK, Gillies CL, Singh R, Singh A,
Chudasama Y, Coles B, Seidu S, Zaccardi F, Davies MJ, Khunti K. Prevalence of
co-morbidities and their association with mortality in patients with COVID-19:
A systematic review and meta-analysis. Diabetes Obes Metab. 2020
Oct;22(10):1915-1924. doi: 10.1111/dom.14124. Epub 2020 Jul 16. PMID: 32573903;
PMCID: PMC7361304.
3. You J, Zhang L, Ni-Jia-Ti MY, Zhang J,
Hu F, Chen L, Dong Y, Yang K, Zhang B, Zhang S. Anormal pulmonary function and
residual CT abnormalities in rehabilitating COVID-19 patients after discharge.
J Infect. 2020 Aug;81(2):e150-e152. doi: 10.1016/j.jinf.2020.06.003. Epub 2020
Jun 4. PMID: 32512021; PMCID: PMC7273134.
5. Mo X, Jian W, Su Z, Chen M, Peng H,
Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19
patients at time of hospital discharge. Eur Respir J. 2020 Jun
18;55(6):2001217. doi: 10.1183/13993003.01217-2020. PMID: 32381497; PMCID:
PMC7236826.
6. Shi H, Han X, Jiang N, Cao Y, Alwalid
O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19
pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020
Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24. PMID:
32105637; PMCID: PMC7159053.
7. Larici AR, Cicchetti G, Marano R,
Merlino B, Elia L, Calandriello L, Del Ciello A, Farchione A, Savino G, Infante
A, Larosa L, Colosimo C, Manfredi R, Natale L. Multimodality imaging of
COVID-19 pneumonia: from diagnosis to follow-up. A comprehensive review. Eur J
Radiol. 2020 Oct;131:109217. doi: 10.1016/j.ejrad.2020.109217. Epub 2020 Aug
17. Erratum in: Eur J Radiol. 2021 Jan;134:109364. PMID: 32861174; PMCID:
PMC7430292.
8. Zhao YM, Shang YM, Song WB, Li QQ, Xie
H, Xu QF, Jia JL, Li LM, Mao HL, Zhou XM, Luo H, Gao YF, Xu AG. Follow-up study
of the pulmonary function and related physiological characteristics of COVID-19
survivors three months after recovery. EClinicalMedicine. 2020 Aug;25:100463.
doi: 10.1016/j.eclinm.2020.100463. Epub 2020 Jul 15. PMID: 32838236; PMCID:
PMC7361108.
9. Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh
PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and
coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J
Antimicrob Agents. 2020 Mar;55(3):105924. doi:
10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17. PMID: 32081636; PMCID:
PMC7127800.
10. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z,
Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y,
Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19
in Wuhan, China: a retrospective cohort study. Lancet 395:
1054–1062, 2020. doi:10.1016/S0140-6736(20)30566-313.
11. Naik PK,
Moore BB. Viral infection and aging as cofactors for
the development of pulmonary fibrosis. Expert
Rev Respir Med 4: 759–771, 2010.
doi:10.1586/ers.10.73.
12.
Kalra, M. K., Maher, M. M., Rizzo, S., Kanarek, D., & Shepard, J. A.
(2004). Radiation exposure from chest CT: issues and strategies. Journal of
Korean medical science, 19(2), 159–166.
