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NCT03258619: NARCOSE
Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock
trial testing Aldosterone / renin dosage in Septic Shock in 40 participants. Completed in 15 November 2017.
15 November 2017
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire Dijon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 27 February 2017 |
| Primary completion | 15 November 2017 |
| Estimated completion | 15 November 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- Aldosterone / renin dosage — full drug profile →
- Natriuresis — full drug profile →
Conditions studied
- Septic Shock — all drugs for Septic Shock →
Sponsor
Centre Hospitalier Universitaire Dijon
Who can join
Adults 18 to 85, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03258619
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Related trials
Other recruiting trials for Septic Shock
Currently open trials in the same condition.
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- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
- NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting
Other Centre Hospitalier Universitaire Dijon trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03258619 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire Dijon
- Last refreshed: 28 February 2024
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