Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates
Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arterial Hypotension
Intervention: Dobutamine (Drug); Dopamine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s): Manuel B Schmid, Dr. med., Principal Investigator, Affiliation: Ulm University
Overall contact: Manuel B Schmid, Phone: +49 731 500, Ext: 57218, Email: manuel.schmid@uni-ulm.de
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cerebral tissue oxygen saturation
Secondary outcome: Cardiac outputCardiac output
Eligibility
Minimum age: N/A.
Maximum age: 44 Weeks.
Gender(s): Both.
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
Locations and Contacts
Manuel B Schmid, Phone: +49 731 500, Ext: 57218, Email: manuel.schmid@uni-ulm.de
University Medical Center, Ulm University, Ulm, Baden-Württemberg 89075, Germany; Recruiting Manuel B Schmid, Phone: +49 731 500, Ext: 57218, Email: manuel.schmid@uni-ulm.de
Additional Information
Starting date: June 2011
Last updated: July 24, 2012
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