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Early Low Dose Vasopressin in fluid refractory pediatric septic shock : a double blind RCT

Early Low Dose Vasopressin Versus Standard Care in Fluid Refractory Pediatric Septic Shock: A Double-Blind, Randomized, Placebo-Controlled Trial - ELDoVASSP

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059841
Enrollment
190
Registered
2023-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: B998- Other infectious disease

Interventions

Intervention1: Low dose vasopressin: Children with fluid refractory septic shock will be randomized in two groups and will receive either low dose vasopressin at 0.0005u/kg/min or placebo for 24 hrs C

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with fluid refractory septic shock

Exclusion criteria

Exclusion criteria: Age Post cardiac arrest or ongoing cardiopulmonary resuscitation Already on vasoactive drugs from referring hospital or prior to enrolment. Patients of diabetes insipidus (DI) or syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Patients with severe hyponatremia ( Chronic kidney disease Chronic liver disease Refused consent by the parents/guardians

Design outcomes

Primary

MeasureTime frame
Resolution of shockTimepoint: 6 hr

Secondary

MeasureTime frame
Shock resolution at 1 and 4 hours of enrolment. Time (in hours) to achieve the therapeutic endpoints of shock resolution. Pediatric Logistic Organ Dysfunction (PELOD) score Vasoactive inotrope score (VIS) Vasoactive free days at day 28 PICU free days at day 28 In-hospital mortality Timepoint: 1 hr,4hr, 24 hr, 28 days

Countries

India

Contacts

Public ContactDr Suresh Angurana

Post Graduate Institute of Medical Education and Research Chandigarh

kumar.suresh@pgimer.edu.in9855373969

Outcome results

None listed

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