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CompletedNCT03258619NARCOSEUpdated Feb 28, 2024

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

An observational study in Septic Shock, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Septic Shock
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • BiologicalAldosterone / renin dosage

    Plasma levels of aldosterone and renin

  • BiologicalNatriuresis

    natriuresis levels

05

What researchers measure

Primary outcomes

  1. Variation in doses of noradrenaline

    Time frame: Day 3

06

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
07

Registry details

Key details

Study ID
NCT03258619
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Feb 27, 2017
Primary completion
Nov 15, 2017
Completion
Nov 15, 2017
Last update
Feb 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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