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

Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05348759
Collaborator
(none)
100
1
6
16.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pulmonary function test
  • Diagnostic Test: Chest computer scan

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Follow-up Study of the Pulmonary Function and CT Scan Finding in Chronic Kidney Disease Patients After COVID-19 Infection
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Chest CT in ESRD patients after recovered from COVID-19 [3 months]

    Chest CT scan

  2. Pulmonary s function tests in ESRD patients after recovered from COVID-19 [3 months]

    Pulmonary function test

Secondary Outcome Measures

  1. Factors affecting the pumonary sequalae after COVID-19 in CKD patients [3 months]

    oxygen requirement

  2. Factors affecting the pumonary sequalae after COVID-19 in CKD patients [3 months]

    Ventilator needed

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

    Interleukin-6 level

  4. Factors affecting the pumonary sequalae after COVID-19 in CKD patients [3 months]

    C-reactive protein level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine ,Vajira hospital,Navamindradhiraj University Bangkok Thailand 10300

Sponsors and Collaborators

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier:
NCT05348759
Other Study ID Numbers:
  • 302/64E
First Posted:
Apr 27, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022