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

Primary Purpose

Arterial Hypotension

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Dobutamine
Dopamine
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypotension

Eligibility Criteria

undefined - 44 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center, Ulm University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dobutamine

Dopamine

Arm Description

Start Dobutamine. If no success switch to Dopamine.

Start Dopamine. If no success switch to Dobutamine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiac output
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Cardiac output
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry

Full Information

First Posted
August 31, 2011
Last Updated
April 5, 2016
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT01427686
Brief Title
Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dobutamine
Arm Type
Active Comparator
Arm Description
Start Dobutamine. If no success switch to Dopamine.
Arm Title
Dopamine
Arm Type
Active Comparator
Arm Description
Start Dopamine. If no success switch to Dobutamine.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral tissue oxygen saturation
Description
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
Time Frame
during study medication
Secondary Outcome Measure Information:
Title
Cardiac output
Description
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Time Frame
during treatment
Title
Cardiac output
Description
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Time Frame
during study medication

10. Eligibility

Sex
All
Maximum Age & Unit of Time
44 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel B Schmid, Dr. med.
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center, Ulm University
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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