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Comparing between hydrocortisone and combination of dexamethasone with fludrocortisone for increasing blood pressure in adult patients with low blood pressure due to severe infections: a double blinded non inferiority randomized controlled trial

Effectiveness of hydrocortisone v/s combination of dexamethasone with fludrocortisone for shock reversal in adult patients with septic shock: a double blinded non inferiority randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072034
Enrollment
80
Registered
2024-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Dexamethasone with Fludrocortisone: Patients randomized to this group will get IV Dexamethasone 2mg QID and tablet Fludrocortisone 100ug OD for 7 days or till shock reversal or till dea

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients presenting with septic shock to ICU requiring vasopressors to maintain mean arterial pressure more than or equal to 65mmHg for at least 4 hours.

Exclusion criteria

Exclusion criteria: Patients already on steroids or likely to be on steroids for reasons other than septic shock. Patient refusal known allergies to study drugs.

Design outcomes

Primary

MeasureTime frame
Time for shock reversal, defined as time from initiation of steroid therapy to discontinuation of noradrenaline for 24 hours to a target MAP of 65mmHg.Timepoint: at every 24 hours for 7 days.—

Secondary

MeasureTime frame
To compare between the two groups 1) ICU mortality rate 2)proportion of patients requiring reinitiation of norepinephrine 3) mean daily insulin requirement during steroid therapy 4)mean number of episodes of hyperglycemia during steroid therapy. 5) proportion of new onset gastrointestinal bleed during steroid therapy 6) proportion of patients requiring transfusion due to gastrointestinal bleed. 7)proportion of patients showing new positive culture from a previously sterile site after initiating steroid therapy. Timepoint: at every 24 hours for 7 days.—

Countries

India

Contacts

Public ContactBoney John

AIIMS Bhubaneswar

anaes_jayanta@aiimsbhubaneswar.edu.in9433798583

Outcome results

None listed

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