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
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Dobutamine
Start Dobutamine. If no success switch to Dopamine.
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.
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.
- 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
- Cardiac output [ Time Frame: during treatment ]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
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
|University Medical Center, Ulm University|
|Ulm, Baden-Württemberg, Germany, 89075|
|Principal Investigator:||Manuel B Schmid, Dr. med.||University of Ulm|