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Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults

NCT04492280 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-07-30

No results posted yet for this study

Summary

During Infection, oflfending microbes interact with the host immune system producing a downstream inflammatory cascade involving cytokines and other mediators, which in turn triggers a systemic response. The resultant effects linclude vasodilation, increased vascular permeability, myocardial depression, and impairment of the coagulation cascade, resulting in global imbalance of systemic oxygen supply and demand. During the late stage of sepsis, immunosuppression predominates, leading to multi-organ dysfunction and further clinical deterioration .

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection with two or three on Quick Sepsis-related organ failure assessment score (qSOFA). Septic shock is defined as the presence of sepsis and refractory hypotension to fluid management. Vasopressors are needed to maintain systolic blood pressure more than 90mmHg or mean blood pressure more than 65 mmHg .

Experimental and Clinical evidence suggests that sepsis is associated with dysregulated response of Hypothalamic-pituitary-adrenal axis that may involve any of the steps from cortisol production to cortisol use by cells .

Glucocorticoid therapy for the treatment of septic shock remains controversial, with conflicting evidence regarding a mortality benefit. It has been used in patients with septic shock who remained hypotensive after fluid and vasopressor resuscitation.

Fludrocortisone is a corticosteroid and acts as a powerful mineralocorticoid along with some additional but comparatively very weak glucocorticoid activity. Relative to cortisol, it is to 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency .

Fludrocortisone is added to hydrocortisone to provide additional mineralocorticoid potency. The rationale for adding mineralocorticoid treatment is that an experimental sepsis study showed marked nuclear factor NF-κB mediated down regulation of vascular mineralocorticoid receptors .

Corticosteroids attenuate inflammation in various organs an effect partly related to inhibition of nuclear factor NF-κB. Improve cardiovascular function by restoring effective blood volume through increased mineralocorticoid activity and by increasing systemic vascular resistance through vascular α-Adrenergic responsiveness and reduces inflammation-mediated vasodilation .

Conditions

  • Septic Shock

Interventions

DRUG

Hydrocortisone

After approval of the ethical committee of faculty of Medicine Ain Shams University and obtaining a written informed consent from all patients or their legal guardians, the study will be conducted on 66 patients subdivided randomly via computer closed envelopes method into 3 equal groups, 22 patients for each group; group HF (hydrocortisone \& fludrocortisone), group H (hydrocortisone) and group C (control group).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492280 on ClinicalTrials.gov