Comparison of two drugs (Epinephrine and Dopamine) for achieving hemodynamic stability (normal blood pressure and adequate cardiac output) in newborn babies with septic shock
- Conditions
- Health Condition 1: null- Septic shock
- Registration Number
- CTRI/2015/10/006285
- Lead Sponsor
- PGIMERChandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
a.Shock diagnosed as hypotension ( <5th centile
according to Zubrowâ??s charts)48
b.Presence of fluid refractory shock. Fluid
refractory shock5,10,40 is defined as the
presence of signs of septic shock despite fluid
challenge (two boluses of 10 ml / kg each given
over 15-20 minutes each).
c.Peripheral circulatory dysfunction - Two of the
following
• Oliguria: urine output < 0.5 ml /kg / hr.
•Prolonged capillary refill: >4 sec.
•Core to peripheral temperature gap > 3ï?° C
(Term)
•Unexplained metabolic acidosis: base
deficit > 5.0 mEq / L.
•Increased arterial lactate > 2 times upper
limit of normal
1.Presence of lethal congenital malformations.
2.Hypovolemic shock- setting of blood loss (ante
partum hemorrhage, obvious blood loss, clinical
features of dehydration ie setting of fluid
loss and / or depressed anterior fontanel,
sunken eyeballs.
3.Baby diagnosed or suspected to have Duct
dependent congenital heart disease.
4.Suspected or proven Cardiogenic shock- setting
of Lt to Rt shunt with no evidence of sepsis
5.Shock in VLBW Babies in first 12 hrs of life,
who donâ??t have settings of sepsis.
6.Severe birth asphyxia with evidence of HIE II or
III in term / near-term neonates of 36 weeks
(Sarnat staging) or moderate / severe
encephalopathy (Levene classification) in
preterm neonates of < 36 weeks.
7.Shock in VLBW Babies in first 12 hrs of life,
who donâ??t have settings of sepsis
8.Baby already on vasopressors.
9.Study investigator to perform
echocardiography is not available
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.The primary outcome variable will be reversal of signs of septic shock. The reversal of signs of septic shock will be defined as a composite outcome of all of the following: <br/ ><br>A.Systolic and diastolic blood pressure more than 5th centile in Zubrowâ??s chart. <br/ ><br>B.Capillary refill time of 3 sec independently assessed by two observers. <br/ ><br>C.Left ventricular output of â?¥150 mL/kg/min. <br/ ><br>Timepoint: 1 hr 30 in <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method <br/ ><br>1.Total time to achieve hemodynamic stability. <br/ ><br>2.Duration of all vasoactive drug use. <br/ ><br>3.Proportion of neonates requiring other vasoactive drugs <br/ ><br>4.Change in metabolic acidosis, lactate from baseline. <br/ ><br>5.All-cause mortality till 28 days of life <br/ ><br>6.Incidence of IVH, BPD, NEC, ROP <br/ ><br>7.Change in cardiac output, ejection fraction and Celiac / Middle cerebral artery blood flow from baseline.Timepoint: Not fixed