Health Condition 1: null- Septic shock
Conditions
Interventions
Intervention1: DOPAMINE and EPINEPHRINE: DOPAMINE vs EPINEPHRINE AS FIRST LINE VASOACTIVE DRUG IN NEONATAL SEPTIC SHOCK: A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL
Intervention2: Inj ADRENALINE: Durin
Sponsors
PGIMERChandigarh
Eligibility
Inclusion criteria
Inclusion criteria: a.Shock diagnosed as hypotension ( 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 • 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: A.Systolic and diastolic blood pressure more than 5th centile in Zubrowâ??s chart. B.Capillary refill time of 3 sec independently assessed by two observers. C.Left ventricular output of â?¥150 mL/kg/min. Timepoint: 1 hr 30 in | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Total time to achieve hemodynamic stability. 2.Duration of all vasoactive drug use. 3.Proportion of neonates requiring other vasoactive drugs 4.Change in metabolic acidosis, lactate from baseline. 5.All-cause mortality till 28 days of life 6.Incidence of IVH, BPD, NEC, ROP 7.Change in cardiac output, ejection fraction and Celiac / Middle cerebral artery blood flow from baseline.Timepoint: Not fixed | — |
Countries
India
Contacts
Public ContactKishore B
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Outcome results
None listed