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A Clinical trial to compare two fluid protocol (restrictive and conventional) in children with septic shock after initial stabilization with respect to length of PICU stay, ventilator free days, organ failure free days, inotrope requirement and mortality

CONVENTIONAL VS. RESTRICTIVE MAINTENANCE FLUID REGIME IN CHILDREN WITH SEPTIC SHOCK AFTER INITIAL RESUSCITATION: A RANDOMIZED OPEN LABEL CONTROLLED PILOT TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003468
Enrollment
100
Registered
2013-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- septic shock after initial resuscitation

Interventions

Intervention1: Restrictive fluid strategy: Fluid intake was curtailed either by restricting the amount of fluid intake and/or diuretic (frusemide)infusion based on the every 12 hourly estimated cumula

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3 months to 12 completed year admitted to emergency/PICU that fulfilled the criteria for septic shock as per the definition of International pediatric sepsis consensus conference: 2005.

Exclusion criteria

Exclusion criteria: 1. Inotrope requirement > 0.3mcg/kg/min of combined total of Epinephrine and Nor-Epinephrine infusion. 2. Child with severe malnutrition ( 4. Child with clinically suspected cardiogenic shock/myocarditis/acquired and congenital heart diseases. 5. Children with raised ICP. 6. Cardiopulmonary arrest prior to randomization. 7. Patients with known immunodeficiency condition, malignancies and/or on chemotherapy. 8. Patient with fulminant liver failure 9. Patients with nephrotic syndrome or protein loosing enteropathies. 10. Patients who had received IV fluids from outside for more than 24 hours prior to presentation.

Design outcomes

Primary

MeasureTime frame
Length of PICU stayTimepoint: Until child weaned off ventilator as well as off inotropes or The end of protocol (10 days) Whichever is earlier

Secondary

MeasureTime frame
1. All cause mortality at 60 days. 2. Organ failure free days from day 1 to day 28. 4. Ventilation free days from day 1 to 28days. 5. Number of organ failures in two groups. 6. Inotrope requirement. 7. Incidence and severity of Acute Lung Injury (ALI) and Acute Kidney Injury (AKI). Timepoint: child is weaned off ventilator as well as off inotropes or The end of protocol (10 days) Whichever is earlier

Countries

India

Contacts

Public ContactSunit Singhi

PGIMER, CHANDIGARH

sunit.singhi@gmail.com01722755301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026