NCT05418855

Brief Summary

The aim of the present work is to determine the frequency of critical complications of SLE patients admitted to the intensive care unit,study the risk factors and out comes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

February 4, 2022

Last Update Submit

June 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • complications of SLE patients admitted to the intensive care unit.

    Number of incidence of complications depending on these measures will be reported Liver bilrubin alb Urea creatinine GFR CBC Ecg X Ray chest cardiomegaly effusion pulmonary edema Ct brain hge infarction Blood gases Clinical data Fever Blood pressure

    Baseline

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients fulfill the Systemic lupus international Collaborating Clinics (SLICC) Criteria for classification of SLE .

You may qualify if:

  • SLE Patients Admitted to ICU.

You may not qualify if:

  • Patients who stayed \<48 h in ICU.
  • Patients with major chronic organ disease not related to SLE or terminal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ahmed Bahy Ahmed, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Fawzy Hussein, Resident

CONTACT

Salwa Salah Elgendi, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at critical care unit of internal medicine department at Assiut University Hospitals

Study Record Dates

First Submitted

February 4, 2022

First Posted

June 14, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

June 14, 2022

Record last verified: 2022-06