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Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock (NARCOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aldosterone

Intervention Details:
  • Biological: Aldosterone / renin dosage
    Plasma levels of aldosterone and renin
  • Biological: Natriuresis
    natriuresis levels

Primary Outcome Measures :
  1. Variation in doses of noradrenaline [ Time Frame: Day 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients hospitalised for septic shock

Inclusion Criteria:

  • persons who have consented to take part
  • Patients aged 18 to 85 years
  • Admitted to an ICU for a first episode of septic shock
  • With a dose of noradrenaline ≥ 0.25µg/kg/min
  • Undergoing treatment with Hydrocortisone Hemisuccinate (HCHS)

Exclusion Criteria:

  • Adult under guardianship
  • Patients without national health insurance cover
  • Pregnant or breast-feeding women
  • Immunodepression (AIDS, corticosteroid treatment > 3 weeks, Organ graft, treatment with immunosuppressants)
  • Recent intake of diuretics (< 6 h)
  • Long-term ACE inhibitors or ARAII
  • Chronic kidney failure (clearance < 60)
  • Cirrhosis Child ≥ B
  • Chronic heart failure (NYHA III and IV)
  • Decision to limit or to stop treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03258619

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Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Bélaïd BOUHEMAD    0380293528   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT03258619    
Other Study ID Numbers: Bouhemad-Nguyen 2016
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome