Health Condition 1: I95-I99- Other and unspecified disorders of the circulatory system
Conditions
Interventions
Intervention1: Vasopressin: Intravenous Epinephrine 1 in 10000 0.1 ml per kg,
Vasopressin 0.8 IU/kg shall be given as bolus doses, every three minutes until return of spontaneous circulation is achiev
Sponsors
The Director
Eligibility
Inclusion criteria
Inclusion criteria: All patients aged One-month (corrected) to 13 years of adult parents, admitted in pediatric intensive care unit, who require cardiopulmonary resuscitation will be included.
Exclusion criteria
Exclusion criteria: 1. Not able to achieve intravenous or intraosseous access during CPR. 2. ROSC achieved by defibrillation without requirement of Epinephrine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare proportion of patients to achieve the return of spontaneous circulation (ROSC) during pediatric cardio-pulmonary resuscitation in combination of Epinephrine and Vasopressin versus Epinephrine and placebo groups.Timepoint: at end of CPR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the survival rate at 24-hour, at Pediatric Intensive Care Unit, at hospital and at 90-days of discharge between the two study groups.Timepoint: 90 days;2. To compare the functional status (as per Pediatric Cerebral Performance Category Scale & Pediatric Overall Performance Category Scale) between two study groups at Pediatric Intensive Care Unit, at hospital and at 90-days of dischargeTimepoint: 90 days;3. To compare the organ support therapy requirement(s) in the two study groups (namely mechanical ventilation & duration, vasoactive therapy & duration, renal replacement therapy & duration, and intracranial pressure monitoring & duration).Timepoint: At PICU discharge;4. To compare the length of stay in pediatric intensive care unit and in hospital in the two study groups.Timepoint: At PICU discharge;5. To compare the number of cardiac arrests requiring resuscitation in the two groups.Timepoint: At PICU discharge;6. To compare the adverse effects(s) of the study drugs.Timepoint: At PICU discharge | — |
Countries
India
Contacts
Public ContactDr Ramesh Kumar R
JIPMER
Outcome results
None listed