Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354946
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Brief Title:
External Validation of Simplified 4C Mortality Score by Deleting CRP
Sponsor:
University of Monastir
Organization:
University of Monastir
Study Overview
Official Title:
External Validation of Simplified 4C Mortality Score by Deleting CRP
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
4Cs
Brief Summary:
The Coronavirus Clinical Characterisation Consortoum 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium ISARIC based on eight different parameters age sex number of comorbidities respiratory rate peripheral oxygen saturation level of consciousness Glasgow Coma Scale urea or blood urea nitrogen BUN level and C reactive protein CRP It was derived and internally validated on a large diverse cohort within the United Kingdom but requires external validity to confirm its generalizability A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use we aim to validate a modified 4C score
Detailed Description:
The clinical presentation and progression of COVID-19 in patients is highly variable which makes it difficult for clinicians to triage patients and determine their prognostic risk
The Coronavirus Clinical Characterisation Consortoum 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium ISARIC based on eight different parameters age sex number of comorbidities respiratory rate peripheral oxygen saturation level of consciousness Glasgow Coma Scale urea or blood urea nitrogen BUN level and C reactive protein CRP It was derived and internally validated on a large diverse cohort within the United Kingdom but requires external validity to confirm its generalizability A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use The study aim to validate a modified 4C score
Methods
This is a multicenter retrospective observational cohort study of patients admitted to five Tunisian university hospitals Fattouma Bourguiba Hospital Monastir Sahloul Hospital Sousse Farhat Hached Hospital Sousse Taher Sfar Hospital Mahdia Habib Bourguiba Hospital Sfax Traumatology and Burns Center Tunis the study included medical records of all adult patients with confirmed COVID-19 infection who were hospitalized from January 2020 and November 2022 A confirmed case of COVID-19 was defined by a positive reverse transcriptase-PCR RT-PCR assay of a nasopharyngeal swab associated with compatible clinical manifestations Incomplete electronic record were excluded from the analysis
Anamnesis clinical paraclinical radiological and outcome data were collected using a validated electronic case report form eCRF The primary outcomes measure was in-hospital death from any cause
The Coronavirus Clinical Characterisation Consortoum 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium ISARIC based on eight different parameters age sex number of comorbidities respiratory rate peripheral oxygen saturation level of consciousness Glasgow Coma Scale urea or blood urea nitrogen BUN level and C reactive protein CRP It was derived and internally validated on a large diverse cohort within the United Kingdom but requires external validity to confirm its generalizability A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use The study aim to validate a modified 4C score
Methods
This is a multicenter retrospective observational cohort study of patients admitted to five Tunisian university hospitals Fattouma Bourguiba Hospital Monastir Sahloul Hospital Sousse Farhat Hached Hospital Sousse Taher Sfar Hospital Mahdia Habib Bourguiba Hospital Sfax Traumatology and Burns Center Tunis the study included medical records of all adult patients with confirmed COVID-19 infection who were hospitalized from January 2020 and November 2022 A confirmed case of COVID-19 was defined by a positive reverse transcriptase-PCR RT-PCR assay of a nasopharyngeal swab associated with compatible clinical manifestations Incomplete electronic record were excluded from the analysis
Anamnesis clinical paraclinical radiological and outcome data were collected using a validated electronic case report form eCRF The primary outcomes measure was in-hospital death from any cause
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None