Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection

September 26, 2022 updated by: RenJi Hospital
By collecting the clinical data of hemodialysis patients with Omicron infection in RenJi Hospital from April 7, 2022 to June 10, 2022, the clinical characteristics of this population were analyzed. And to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a single-center, retrospective, observational study. The research subjects were hemodialysis patients admitted to the Hemodialysis Center of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine because of omicron infection during the Omicron epidemic period from April 7, 2022 to June 10, 2022. 65 cases were included in the study after excluding those patients who underwent hemodialysis due to acute kidney injury. And they were compared with 195 non-dialysis patients admitted to the hospital in the same period,who were randomly selected, according to the ratio of 1:3.

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Renji Hospital, School of Medicine, Shanghai Jiaotong 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with omicron infection

Description

Inclusion Criteria:

  • Hemodialysis patients due to chronic kidney disease stage 5 with omicron infection

Exclusion Criteria:

  • Patients on hemodialysis due to acute kidney injury

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hemodialysis patients with omicron infection
Other: no intervention
no intervention
non-hemodialysis patients with omicron infection
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral elimination
Time Frame: 2022-4-7 to 2022-6-10
both negative for ORF1ab and N genes (Ct value ≥35 by real-time PCR) in two consecutive days.
2022-4-7 to 2022-6-10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular events
Time Frame: 2022-4-7 to 2022-6-10
including acute left heart failure, new symptomatic arrhythmias requiring drug control, acute coronary syndrome
2022-4-7 to 2022-6-10

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Director: Jiayue Lu, Renji Hospital affiliation to Shanghai Jiao Tong University School of Medicine

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)

July 1, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2022-0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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