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Effects of Midodrine and Fludrocortisone in Patients with Septic Shock

Comparison of the effects of midodrine and fludrocortisone in septic shock patients admitted to the ICU

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250504065597N1
Enrollment
80
Registered
2025-10-04
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Septic shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: Midodrine 5 mg orally every 12 hours for 7 days (manufactured by Pars behrozan Jam). Intervention 2: Intervention group: Fludrocortisone 0.1 mg orally every 12 hou

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients aged over 18 and under 90 years old. Admission to the Intensive Care Unit (ICU) and treatment for septic shock Patients with a mean arterial pressure (MAP) less than 65 mmHg after receiving antibiotics and initial IV fluid resuscitation of 30 ml/kg.

Exclusion criteria

Exclusion criteria: History of advanced hepatic or renal disease Presence of evidence of left ventricular systolic dysfunction or cardiogenic shock, Serum lactate level greater than 4 mmol/L

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure (MAP) with a value equal to or greater than 65 mmHg. Timepoint: B lood pressure (MAP) will be recorded every 4 hours for 24 hours starting from the administration of the first dose. Thereafter, patients will be monitored daily for the next 7 days. Method of measurement: Continuous monitoring in the ICU.

Secondary

MeasureTime frame
Dose of vasopressor drugs administered during the study period. Timepoint: Outcome measurements from the initiation of the intervention up to seven days thereafter on a daily basis. Method of measurement: The dose and duration of vasopressor therapy, including norepinephrine, vasopressin, epinephrine, dopamine, and phenylephrine, will be continuously monitored and accurately recorded based on the patients medical records.;Serum Lactate Clearance. Timepoint: Assessments will be conducted at the beginning of the study (before the intervention), 24 hours after the start of the intervention, on day 3 after the start of the intervention, and on day 7 after the start of the intervention. Method of measurement: Using the ABL800 FLEX Blood Gas Analyzer.;Length of Stay in ICU. Timepoint: From ICU admission until ICU discharge. Method of measurement: Electronic medical records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeied Hadi Saghaleini

Tabriz University of Medical Sciences

hsaghaleini@gmail.com+98 41 3541 2101

Outcome results

None listed

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