Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

Arterial Hypotension Clinical Trial

Official title:

Effect of Dobutamine as Compared to Dopamine on Cerebral Oxygenation, Mean Arterial Pressure and Cerebral Hemodynamics in Term and Preterm Neonates With Arterial Hypotension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01427686
• Other study ID #: ULMNEONIRS01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: April 5, 2016
• Start date: June 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.

The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 44 Weeks

Eligibility

Inclusion Criteria:

• fluid refractory arterial hypotension

• newborn infant below 44 weeks postmenstrual age

• parental informed consent

Exclusion Criteria:

• preterm infant below 28 weeks postmenstrual age during the first week of life

• congenital life-threatening malformations

• decision for palliative care

• hemorrhagic shock

• other obvious cause for arterial hypotension that requires immediate specific treatment, e.g. tension pneumothorax

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Hypotension
• Hypotension

Intervention

Drug:
• Dobutamine
Start Dobutamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dopamine.
• Dopamine
Start Dopamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dobutamine.

Locations

Country	Name	City	State
Germany	University Medical Center, Ulm University	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral tissue oxygen saturation	Cerebral tissue oxygen saturation (and derived parameters FTOE, HbD and Total Hb as secondary outcomes) measured by near-infrared spectroscopy after achieving normal blood pressure	during study medication	No
Secondary	Cardiac output	Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry	during treatment	No
Secondary	Cardiac output	Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry	during study medication	No