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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03258619
Acronym
NARCOSE
Enrollment
40
Registered
2017-08-23
Start date
2017-02-27
Completion date
2017-11-15
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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.

Interventions

BIOLOGICALAldosterone / renin dosage

Plasma levels of aldosterone and renin

BIOLOGICALNatriuresis

natriuresis levels

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variation in doses of noradrenalineDay 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026