Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741762
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-02-02
Brief Title:
Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit
Sponsor:
Dr Adnan Agha
Organization:
United Arab Emirates University
Study Overview
Official Title:
Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit A Single Centre Real World Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
Critical illness-related corticosteroid insufficiency CIRCI a term coined since 2008 by Society of Critical Care Medicine SCCM and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive Care Unit ICU patients1 Severe Sepsis with shock is a common reason for admission to ICUhospital and may require ionotropic support2 The current guidelines from SCCM in 2017 suggest using either random cortisol of 10 ugdL 276 nmolL or change in cortisol at 60 min after cosyntropin 250 µg administration from baseline cortisol of 9 µgdl 248 nmolL to assess of presence of CRCI and recommend use of hydrocortisone in these patients3 There have been studies done to look at baseline cortisol in patient with severe pneumonia requiring ICU and they have found cortisol level of 15 ugdl 414 nmolL can predict CIRCI4 However there is no study on assessment of baseline random cortisol levels in patients with septic shock in our local population The current guidance from Surviving Sepsis campaign suggests a more clinical approach of adding IV corticosteroids only if there is ongoing requirement for vasopressors which is a new change in contrast to 2016 guidelines5
This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population
This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population
Detailed Description:
This is the first study to ascertain the baseline cortisol in patients with septic shock in local Emirati population This will help provide more evidence towards diagnosingruling out CIRCI reliably At present there is no consensus data globally on expected random cortisol levels in patients having septic shock and no data expected random cortisol levels in UAEGulf region in these patients which makes diagnosis of CIRCI difficult Objective
Primary
The aim of this study is to estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support who did not require any hydrocortisone during ICU stay at Tawam hospital United Arab Emirates to obtain a reference for our local population
Secondary
1 To estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support who also required hydrocortisone during ICU stay to obtain a reference for our local population with CIRCI
2 To assess the outcome of patients treated as CIRCI
3 To assess the duration of hydrocortisone-use during ICUhospital
4 To see if the steroids were continued post discharge from ICUhospital
5 To compare biochemical profile of the patients treated with suspected CRICI in comparison to patients not requiring any steroids
Study Type
Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done
Study location ICU Tawam Hospital Al Ain
Study duration The retrospective chart review will be done for patient admitted into ICU between 01062012 to 01062022
Sample Size
Investigators plan to include minimum 400 patients based on study power calculation of minimum 386 patients
INCLUSION CRITERIA
Age 18 both male or female
Any nationality
Patients admitted to ICU with diagnosis of severe sepsis septic shock bearing ICD-10 codes R6520 or R6521 AND
who required ionotropic support within 24-48 hours of admission AND
had a valid cortisol measurement done during this admissionencounter
EXCLUSION CRITERIA
Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock
Patient who received steroids within 24 hours prior to sending cortisol sample
Patient with known adrenal insufficiency
Patient on oralinhaled steroids home medications prior to this admission for any reason equivalent to 75 mg prednisolone or above in the last 6 weeks
Sample Collection Process
This is a retrospective observational study in which records of all patients admitted to ICU with diagnosis of severe sepsis septic shock bearing ICD-10 codes R6520 or R6521 who required ionotropic support within 24 hours of admission and had a valid cortisol measurement done during this admissionencounter will be reviewed The biochemical workup Full blood count liver function and renal function test length of stay in ITU and outcome of the patient including use of steroids during hospital or discharge will be obtained
Consenting Process
It will an observational study no intervention with retrospective analysis of patient records on SalamTek No patient sensitive or identifiable information will be kept on records No individual patient consenting required
Data Handlingconfidentiality Statistical Analysis
The data will be collected on an excel sheet in secure CMHS network with no identifiable patient information This excel sheet will be transferred onto SPSS package for Microsoft Windows version 120 The variables of demography age sex history of present disease duration severity positive signs and routine investigations will be presented as simple descriptive statistics The means and standard deviations of the numerical data such as age Haemoglobin creatinine etc will be calculated The mean first cortisol level prior to any corticosteroid treatment for patients without diagnosis of CRICI who responded to ionotropes will be obtained to see the baseline cortisol level in these patients For patient treated as CIRCI the mean cortisol level will be obtained and comparison analysis via receiver operator curves will be obtained to see if a value of random cortisol can predict absence of CIRCI with at least 95 sensitivity
Primary
The aim of this study is to estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support who did not require any hydrocortisone during ICU stay at Tawam hospital United Arab Emirates to obtain a reference for our local population
Secondary
1 To estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support who also required hydrocortisone during ICU stay to obtain a reference for our local population with CIRCI
2 To assess the outcome of patients treated as CIRCI
3 To assess the duration of hydrocortisone-use during ICUhospital
4 To see if the steroids were continued post discharge from ICUhospital
5 To compare biochemical profile of the patients treated with suspected CRICI in comparison to patients not requiring any steroids
Study Type
Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done
Study location ICU Tawam Hospital Al Ain
Study duration The retrospective chart review will be done for patient admitted into ICU between 01062012 to 01062022
Sample Size
Investigators plan to include minimum 400 patients based on study power calculation of minimum 386 patients
INCLUSION CRITERIA
Age 18 both male or female
Any nationality
Patients admitted to ICU with diagnosis of severe sepsis septic shock bearing ICD-10 codes R6520 or R6521 AND
who required ionotropic support within 24-48 hours of admission AND
had a valid cortisol measurement done during this admissionencounter
EXCLUSION CRITERIA
Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock
Patient who received steroids within 24 hours prior to sending cortisol sample
Patient with known adrenal insufficiency
Patient on oralinhaled steroids home medications prior to this admission for any reason equivalent to 75 mg prednisolone or above in the last 6 weeks
Sample Collection Process
This is a retrospective observational study in which records of all patients admitted to ICU with diagnosis of severe sepsis septic shock bearing ICD-10 codes R6520 or R6521 who required ionotropic support within 24 hours of admission and had a valid cortisol measurement done during this admissionencounter will be reviewed The biochemical workup Full blood count liver function and renal function test length of stay in ITU and outcome of the patient including use of steroids during hospital or discharge will be obtained
Consenting Process
It will an observational study no intervention with retrospective analysis of patient records on SalamTek No patient sensitive or identifiable information will be kept on records No individual patient consenting required
Data Handlingconfidentiality Statistical Analysis
The data will be collected on an excel sheet in secure CMHS network with no identifiable patient information This excel sheet will be transferred onto SPSS package for Microsoft Windows version 120 The variables of demography age sex history of present disease duration severity positive signs and routine investigations will be presented as simple descriptive statistics The means and standard deviations of the numerical data such as age Haemoglobin creatinine etc will be calculated The mean first cortisol level prior to any corticosteroid treatment for patients without diagnosis of CRICI who responded to ionotropes will be obtained to see the baseline cortisol level in these patients For patient treated as CIRCI the mean cortisol level will be obtained and comparison analysis via receiver operator curves will be obtained to see if a value of random cortisol can predict absence of CIRCI with at least 95 sensitivity
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