A study to compare the efficacy of Vasopressin (newer medicine)and Norepinephrine (commonly used medicine) in babies with septic shock

A Double blinded Randomized study to compare the efficacy of Vasopressin versus Norepinephrine determined by improvement in markers of tissue perfusion within first sixty minutes in neonates with fluid refractory septic shock. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071911

Enrollment

146

Registered

2024-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Vasopressin: One arm of the study will be neonates with fluid refractory septic shock who will be treated with Vasopressin. Standard dose of drug will be used, starting from 0.2mU/kg/mi

Eligibility

Inclusion criteria

Inclusion criteria: All neonates admitted to NICU with signs of septic shock.

Exclusion criteria

Exclusion criteria: 1. Septic neonates with poor ventricular contractility on functional ECHO. 2. Pre-existing heart disease (clinically or echocardiographic diagnosed) or arrhythmias. 3. Out born neonates with ongoing sepsis, and on inotropic/vasopressor support prior to enrolment 4. Congenital life-threatening anomalies

Design outcomes

Primary

Measure	Time frame
Improvement in markers of tissue perfusionTimepoint: Sixty minutes of starting drug	—

Secondary

Measure	Time frame
Length of stayTimepoint: at discharge of the baby;MortalityTimepoint: at death of the baby, if the baby expires or at the discharge of the baby;To compare complications of both the drugsTimepoint: at discharge of the baby;To evaluate duration of using vasopressorTimepoint: 7 days;To evaluate safety profile of VasopressinTimepoint: 7 days;To evaluate the need for additional vasopressorTimepoint: 7 days	—

Measure

Time frame

Length of stayTimepoint: at discharge of the baby;MortalityTimepoint: at death of the baby, if the baby expires or at the discharge of the baby;To compare complications of both the drugsTimepoint: at discharge of the baby;To evaluate duration of using vasopressorTimepoint: 7 days;To evaluate safety profile of VasopressinTimepoint: 7 days;To evaluate the need for additional vasopressorTimepoint: 7 days

—

Countries

India

Contacts

Public ContactAnurag Sanjeev Pikle

Bharati Vidyapeeth Deemed University Medical College, Pune

drpradeepsuryawanshi@gmail.com9923540500

Outcome results

None listed

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