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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm
ClinicalTrials.gov Identifier:
NCT01427686
First received: August 31, 2011
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Arterial Hypotension
Drug: Dobutamine
Drug: Dopamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Cerebral tissue oxygen saturation [ Time Frame: during study medication ] [ Designated as safety issue: No ]
    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 [ Time Frame: during treatment ] [ Designated as safety issue: No ]
    Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry

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


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 44 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427686

Contacts
Contact: Manuel B Schmid +49 731 500 ext 57218 manuel.schmid@uni-ulm.de

Locations
Germany
University Medical Center, Ulm University Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Manuel B Schmid    +49 731 500 ext 57218    manuel.schmid@uni-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. Ulm University
  More Information

No publications provided

Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01427686     History of Changes
Other Study ID Numbers: ULMNEONIRS01
Study First Received: August 31, 2011
Last Updated: July 24, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 28, 2014