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

Phase 4

• Conditions: Arterial Hypotension
• Interventions: Drug: Dobutamine; Drug: Dopamine

• Registration Number: NCT01427686
• Lead Sponsor: University of Ulm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2015-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dobutamine	Dobutamine	Start Dobutamine. If no success switch to Dopamine.
Dopamine	Dopamine	Start Dopamine. If no success switch to Dobutamine.

Primary Outcome Measures

Name	Time	Method
Cerebral tissue oxygen saturation	during study medication	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

Secondary Outcome Measures

Name	Time	Method
Cardiac output	during study medication	Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry

Trial Locations

Locations (1)

University Medical Center, Ulm University; 🇩🇪 Ulm, Baden-Württemberg, Germany