Investigating the effect of midodrine in preventing septic shock in childre
Phase 3
Recruiting
- Conditions
- R65.20Preventing septic shock in children with severe sepsis.Severe sepsis without septic shock
- Registration Number
- IRCT20120520009801N14
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <0.5ml/kg/hr, 4- Prolonged capillary refill time >5 seconds, 5- Core to peripheral temperature gap >3oC.
- Secondary Outcome Measures
Name Time Method 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).