Health Condition 1: I958- Other hypotension
Conditions
Interventions
Intervention1: Liberal transfusion strategy: We will transfuse children whose haemoglobin is less than or equal to 9 gm per dL.
Control Intervention1: Restrictive transfusion strategy: We will transfu
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Children admitted to PICU Aged 28 days to 17 years Meeting Phoenix criteria for septic shock Hemoglobin less than 9 g per dl
Exclusion criteria
Exclusion criteria: Patients with malignancies Patients with hemolytic anemias Patients with a hemoglobin level less than 5 g per dl Patients with cyanotic Congenital Heart Disease Patients with Chronic Kidney Disease Patients with an anticipated mortality in the next 24 hours post randomisation Patients who were administered PRBCs during this admission before the child developed shock Life-threatening bleed Need for a surgical procedure requiring higher hemoglobin levels Dengue Shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with shock resolution at 24 hours post-randomisationTimepoint: The proportion of patients with shock resolution at 24 hours post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with shock resolution during ICU stayTimepoint: During ICU stay;To compare the time to shock resolutionTimepoint: TIme duration from onset of shock to resolution;All-cause mortality at 28 days post-randomisationTimepoint: At 28 day post randomisation;Number of patients in both the groups requiring vasoactive drugs within the first 7 days following enrollmentTimepoint: 7 days from randomisation;The incidence of Healthcare-Associated Infections (HAI)Timepoint: During ICU stay;Change in Pediatric Logistic Organ Dysfunction Score (PELOD) from randomisation to Change in Pediatric Logistic Organ Dysfunction Score (PELOD) from randomisation to 24 hrs, 72 hours, and 7 days post randomisationTimepoint: At 24 hrs, 72 hrs and 7 days post randomisation;The incidence of transfusion-related complications between the groupsTimepoint: Upto 28 days of transfusion;The length of PICU stayTimepoint: Throughout PICU stay | — |
Countries
India
Contacts
Public ContactJhuma Sankar
All India Institute of Medical Sciences
Outcome results
None listed