Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit; A Single Centre Real World Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cortisol levels (nmol/L)
研究概览
简要总结
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) patients.1 Severe Sepsis with shock is a common reason for admission to ICU/hospital and may require ionotropic support.2 The current guidelines from SCCM in 2017 suggest using either random cortisol of < 10 ug/dL (<276 nmol/L) or change in cortisol at 60 min after cosyntropin (250 µg) administration from baseline cortisol of <9 µg/dl (<248 nmol/L) to assess of presence of CRCI and recommend use of hydrocortisone in these patients.3 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 ug/dl (<414 nmol/L) can predict CIRCI.4 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 guidelines.5
This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.
详细描述
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 diagnosing/ruling 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 UAE/Gulf 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:
- 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.
- To assess the outcome of patients treated as CIRCI.
- To assess the duration of hydrocortisone-use during ICU/hospital.
- To see if the steroids were continued post discharge from ICU/hospital.
- To compare biochemical profile of the patients treated with suspected CRICI in comparison to patients not requiring any steroids.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18; both male or female
- •Any nationality
- •Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND
- •who required ionotropic support within 24-48 hours of admission, AND
- •had a valid cortisol measurement done during this admission/encounter
排除标准
- •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 oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks
结局指标
主要结局
Cortisol levels (nmol/L)
时间窗: last 5 years
The aim of this study is to measure the mean random cortisol levels (in nmol/L) 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.
次要结局
- outcome of patients (mortality)(last 5 years)
- Treatment for CRICI (total hydrocortisone dosage estimation in mg/day/patient)(last 5 years)
- steroid on discharge requirement(last 5 years)
研究者
Dr Adnan Agha
Assistant Professor, Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University
United Arab Emirates University
