Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock (NARCOSE)
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|ClinicalTrials.gov Identifier: NCT03258619|
Recruitment Status : Unknown
Verified August 2017 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response to the ACTH stimulation test, it is recommended to systematically start steroid replacement therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not respond to fluid resuscitation and who continue to suffer from haemodynamic instability despite increasing doses of noradrenaline.
The interest of this corticosteroid therapy lies in its ability to reduce the duration of treatment with catecholamines, though the results are conflicting with regard to an eventual benefit for mortality.
Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood glucose dysregulation.
Today, there is no way to identify a population of patients who respond to corticosteroid therapy.
From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also exert mineralocorticoid effects able to compensate for the impaired renin angiotensin aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.
This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis >30 mmol/l.
We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who respond to steroid replacement therapy in terms of catecholamine use.
|Condition or disease||Intervention/treatment|
|Septic Shock||Biological: Aldosterone / renin dosage Biological: Natriuresis|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
- Biological: Aldosterone / renin dosage
Plasma levels of aldosterone and renin
- Biological: Natriuresis
- Variation in doses of noradrenaline [ Time Frame: Day 3 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258619
|Chu Dijon Bourgogne||Recruiting|
|Dijon, France, 21000|
|Contact: Bélaïd BOUHEMAD 0380293528 firstname.lastname@example.org|