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

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ClinicalTrials.gov Identifier: NCT01427686
Recruitment Status : Unknown
Verified April 2016 by Manuel Schmid, University of Ulm.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2011
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, 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.


Condition or disease Intervention/treatment Phase
Arterial Hypotension Drug: Dobutamine Drug: Dopamine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2011
Actual Primary Completion Date : February 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cardiac output [ Time Frame: during treatment ]
    Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry

  2. Cardiac output [ Time Frame: during study medication ]
    Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry



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Ages Eligible for Study:   up to 44 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427686


Locations
Germany
University Medical Center, Ulm University
Ulm, Baden-Württemberg, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm

Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01427686     History of Changes
Other Study ID Numbers: ULMNEONIRS01
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Dopamine
Dobutamine
Dopamine Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents