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

February 3, 2023 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Follow-up Study of the Pulmonary Function and CT Scan Finding in Chronic Kidney Disease 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Solos Jaturapisanukul, M.D.
  • Phone Number: 660629165562
  • Email: solos@nmu.ac.th

Study Locations

  • Thailand
      • Bangkok, Thailand, 10300
        • Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chest CT in ESRD patients after recovered from COVID-19
Time Frame: 3 months
Chest CT scan
3 months
Pulmonary s function tests in ESRD patients after recovered from COVID-19
Time Frame: 3 months
Pulmonary function test
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Factors affecting the pumonary sequalae after COVID-19 in CKD patients
Time Frame: 3 months
oxygen requirement
3 months
Factors affecting the pumonary sequalae after COVID-19 in CKD patients
Time Frame: 3 months
Ventilator needed
3 months
Factors affecting the pumonary sequalae after COVID-19 in CKD patients
Time Frame: 3 months
Interleukin-6 level
3 months
Factors affecting the pumonary sequalae after COVID-19 in CKD patients
Time Frame: 3 months
C-reactive protein level
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 302/64E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators planned to share data upon completion of recruitment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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