Investigating the effect of midodrine in preventing septic shock in children

Investigating the effect of midodrine in preventing septic shock in children with severe sepsis hospitalized in the PICU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120520009801N14

Enrollment

Registered

2024-06-30

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Preventing septic shock in children with severe sepsis. Severe sepsis without septic shock

Interventions

Intervention 1: Intervention group: midodrine 2.5 mg tablets, twice daily po, until hemodynamic stability and inotrope interruption (35 people). Intervention 2: Control group: Placebo tablets made by

Eligibility

Sex/Gender

All

Age

1 Months to 10 Years

Inclusion criteria

Inclusion criteria: Age more than 1 month and less than 10 years admitted to PICU with severe sepsis Obtain informed consent from the patient's parents Normal SVRI (1200 - 1600)

Exclusion criteria

Exclusion criteria: Hypertention (mean arterial pressure upper than 80 mmHg) History of Pheochromocytoma Urinary retention Thyrotoxicosis History of taking Midodrine Impairment of liver function (Child-Pugh class C) Very ill patient ( ie. history of cardiopulmonary resuscitation) Having congenital haert disease

Design outcomes

Primary

Measure	Time frame
Occurrence of septic shock. Timepoint: Daily. Method of measurement: Sepsis ( SIRS in the presence of infection) and cardiovascular organ dysfunction, defined as hypotension or need for a vasoactive drug, or two of the following: 1-Metabolic acidosis with base excess >5mMol/L , 2- Raised lactate, 3- Urine output 5 seconds, 5- Core to peripheral temperature gap >3oC.	—

Secondary

Measure	Time frame
Severity of SVRI drop. Timepoint: Daily. Method of measurement: SVRI measuring device.;Required dose of vasopressor in septic shock. Timepoint: Daily. Method of measurement: Checking the dose of vasopressor.;Serum lactate level. Timepoint: Daily. Method of measurement: Blood sample.;Kidney failure ( Serum creatinine =2). Timepoint: Daily. Method of measurement: Serum creatinine in blood sample.;Lliver dysfunction ( total ?Bilirubin > 4 mg/dl or Alanine transaminase> 2 upper limit normal). Timepoint: Daily. Method of measurement: Bilirubin level and Alanine transaminase level in blood sample.;Brain dysfunction. Timepoint: Daily. Method of measurement: Loss of consciousness based on AVPU scoring (Alert, Voice, Pain, Unresponsive).	—

Measure

Time frame

Severity of SVRI drop. Timepoint: Daily. Method of measurement: SVRI measuring device.;Required dose of vasopressor in septic shock. Timepoint: Daily. Method of measurement: Checking the dose of vasopressor.;Serum lactate level. Timepoint: Daily. Method of measurement: Blood sample.;Kidney failure ( Serum creatinine =2). Timepoint: Daily. Method of measurement: Serum creatinine in blood sample.;Lliver dysfunction ( total ?Bilirubin > 4 mg/dl or Alanine transaminase> 2 upper limit normal). Timepoint: Daily. Method of measurement: Bilirubin level and Alanine transaminase level in blood sample.;Brain dysfunction. Timepoint: Daily. Method of measurement: Loss of consciousness based on AVPU scoring (Alert, Voice, Pain, Unresponsive).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hooshang Mohammadpour

Mashhad University of Medical Sciences

mohamadpoorah@mums.ac.ir+98 51 1882 3255

Outcome results

None listed

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