Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06847451
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2025-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Red Cell Distribution Width's Prognostic Ability in Septic Intensive Care Unit Patients
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Red Cell Distribution Width as a Prognostic Factor for Morbidity and Mortality of Intensive Care Unit Patients With Sepsis.
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
Various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. This prospective observational study aims to approach the prognostic value of Red Cell Distribution Width for morbidity and mortality of intensive care unit patients with sepsis. and this will be achieved by:
* Assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality
* Comparison between red cell distribution width and other inflammatory markers as C-reactive protein and serum lactate as well as other scoring systems such as Sequential Organ Failure Assessment (SOFA) score, regarding their prognostic discriminative ability.
* Assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality
* Comparison between red cell distribution width and other inflammatory markers as C-reactive protein and serum lactate as well as other scoring systems such as Sequential Organ Failure Assessment (SOFA) score, regarding their prognostic discriminative ability.
Detailed Description:
Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) will be enrolled.
All patients will be resuscitated and managed according to Ain Shams University Hospitals protocol for sepsis and septic shock.
On admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as C-reactive protein, Arterial blood gas for serum lactate count, and cultures samples according to source of infection. Red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality.
Patient's morbidity will be defined by Sequential Organ Failure Assessment (SOFA) Score, it will be calculated and recorded on admission and will be followed up as well.
All patients will be resuscitated and managed according to Ain Shams University Hospitals protocol for sepsis and septic shock.
On admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as C-reactive protein, Arterial blood gas for serum lactate count, and cultures samples according to source of infection. Red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality.
Patient's morbidity will be defined by Sequential Organ Failure Assessment (SOFA) Score, it will be calculated and recorded on admission and will be followed up as well.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: