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

April 5, 2016 updated by: Manuel Schmid, University of Ulm

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89075
        • University Medical Center, Ulm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dobutamine
Start Dobutamine. If no success switch to Dopamine.
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.
Active Comparator: Dopamine
Start Dopamine. If no success switch to Dobutamine.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral tissue oxygen saturation
Time Frame: 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
during study medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: during treatment
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
during treatment
Cardiac output
Time Frame: during study medication
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
during study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULMNEONIRS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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