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Is the blood pressure corrected by the tablet fludrocortisone in patients with low blood pressure in ICU.

Effectiveness of early administration of fludrocortisone in septic shock: A prospective, Double Blind, Randomized control trial. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077910
Enrollment
154
Registered
2024-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: A00-B99- Certain infectious and parasitic diseases

Interventions

Intervention1: Early administration of oral fludrocortisone in septic shock patients.: Adult patients with septic shock within 24 hours of norepinephrine initiation, oral fludrocortisone 50 micrograms

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with septic shock within 24 hours of initiation of norepinephrine.

Exclusion criteria

Exclusion criteria: Age less than 18 years and more than 75 years. Pregnant and lactating patients, Patients with known history of chronic kidney disease, chronic liver disease, congestive heart failure, patients with hypernatremia and hypokalemia, high vasopressor requirement are excluded from the study

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of early administration of fludrocortisone and vasopressor-free days in early septic shock within the first 14 days of recruitment.Timepoint: At baseline and within first 14 days of recruitment

Secondary

MeasureTime frame
? Duration of shock (Total days on vasopressor) ? Total daily vasopressors dose from days 1to14. ? Change in SOFA in the first seven days of enrolment. ? Ventilator-free days at day 30 after enrolment. ? ICU-free days at day 30 after enrolment. ? Mortality in the first 30 days of recruitment. ? Incidence of hypernatremia ? Incidence of hypokalaemia ? Incidence of hyperglycaemia ? Incidence of RRT ? Change in CRP, IL 6 during the first seven days after recruitment. ? Hospital-acquired infections. Timepoint: At end of 30 days from recruitment.

Countries

India

Contacts

Public ContactViswanath S

AIIMS, New Delhi

drrakesh.kumar.akb@gamil.com8595075008

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026