Dopamine vs epinephrine in neonatal septic shock

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Inj Dopamine: Subjects will be randomized to receive either dopamine or epinephrine at initially doses of 10 μg/kg/min of dopamine or 0.1 μg/kg/min of epinephrine. Baseline parameters will be obtained including vital sign, arterial blood gas, neonatal septic screen and blood cultures. BP will be recorded using multipara monitor with appropriate cuff size (EDAN, iM70 Edan instruments, USA). After initiation of infusion of the study drug, subjects will be assessed at 20, 40 and 60 min interval for reversal of shock. Reversal of shock will be defined as (13) Systolic BP more than 5th percentile for age, with â?¢ Heart rate within normal limit for age, and â?¢ Urine output 1 mL/kg/hr, and â?¢ Capillary refill time less than 3 sec, and â?¢ Normal mental status (except in cases of suspected meningitis and/or on sedation) If shock does not reverse at the 20‐min assessment point, the infusion rate will be increased to epinephrine 0.2 μg/kg/min or dopamine 15 μg/kg/min. If shock persists at the 40‐min assessment point, the infusion rate will be increased to epinephrine 0.3 μg/kg/min or dopamine 20 μg/kg/min. If hypotension persists beyond 60 minutes, the patients in the epinephrine arm will be crossed over to dopamine arm and vice versa. The further management will be according to standard treatment guidelines Control Intervention1: Inj Epinephrine: Subjects will be randomized to receive either dopamine or epinephrine at initially doses of 10 μg/kg/min of dopamine or 0.1 μg/kg/min of epinephrine. Baseline parameters will be obtained including vital sign, arterial blood gas, neonatal septic screen and blood cultures. BP will be recorded using multipara monitor with appropriate cuff size (EDAN, iM70 Edan instruments, USA). After initiation of infusion of the CONDITION: Health Condition 1: P369‐ Bacterial sepsis of newborn, unspecified PRIMARY OUTCOME: Reversal of shock at 60 minutes of starting either dopamine or epinephrine in neonates with fluid refractory septic shockTimepoint: Reversal of shock at 60 minutes of starting either dopamine or epinephrine in neonates with fluid refractory septic shock SECONDARY OUTCOME: 1. All‐cause mortality ; 2. Duration of PICU stay ; 3. Requirement of other ; vasoactive agents ; Timepoint: Till time of discharge INCLUSION CRITERIA: All neonates ( >34 weeks) up to 28 days of life in fluid refractory septic shock admitted in Extra‐mural NICU
Epistemonikos ID: 25a476a0f0ab8624700040d9562b8e266e269e5d
First added on: Feb 20, 2024