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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 output

Cardiac 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-W├╝rttemberg 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

Page last updated: August 23, 2015

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