Clinical Trials Directory

Trials / Completed

CompletedNCT03258619

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAldosterone / renin dosagePlasma levels of aldosterone and renin
BIOLOGICALNatriuresisnatriuresis levels

Timeline

Start date
2017-02-27
Primary completion
2017-11-15
Completion
2017-11-15
First posted
2017-08-23
Last updated
2024-02-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03258619. Inclusion in this directory is not an endorsement.