Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection

COVID-19 Clinical Trial

Official title:

Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559138
• Other study ID #: IIT-2022-0120
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients on hemodialysis due to acute kidney injury

Related Conditions & MeSH terms

• COVID-19
• Infections

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

De Meester J, De Bacquer D, Naesens M, Meijers B, Couttenye MM, De Vriese AS; NBVN Kidney Registry Group. Incidence, Characteristics, and Outcome of COVID-19 in Adults on Kidney Replacement Therapy: A Regionwide Registry Study. J Am Soc Nephrol. 2021 Feb; — View Citation

Halfmann PJ, Iida S, Iwatsuki-Horimoto K, Maemura T, Kiso M, Scheaffer SM, Darling TL, Joshi A, Loeber S, Singh G, Foster SL, Ying B, Case JB, Chong Z, Whitener B, Moliva J, Floyd K, Ujie M, Nakajima N, Ito M, Wright R, Uraki R, Warang P, Gagne M, Li R, S — View Citation

Lewnard JA, Hong VX, Patel MM, Kahn R, Lipsitch M, Tartof SY. Clinical outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) variant and BA.1/BA.1.1 or BA.2 subvariant infection in Southern California. Nat Med. 2022 Sep;28(9):1933-1943. doi: 10.1038/s41 — View Citation

Shuai H, Chan JF, Hu B, Chai Y, Yuen TT, Yin F, Huang X, Yoon C, Hu JC, Liu H, Shi J, Liu Y, Zhu T, Zhang J, Hou Y, Wang Y, Lu L, Cai JP, Zhang AJ, Zhou J, Yuan S, Brindley MA, Zhang BZ, Huang JD, To KK, Yuen KY, Chu H. Attenuated replication and pathogen — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral elimination	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	cardiovascular events	including acute left heart failure, new symptomatic arrhythmias requiring drug control, acute coronary syndrome	2022-4-7 to 2022-6-10