Overview

This trial is active, not recruiting.

Condition arterial hypotension
Treatments dobutamine, dopamine
Phase phase 4
Sponsor University of Ulm
Start date June 2011
End date February 2015
Trial size 20 participants
Trial identifier NCT01427686, ULMNEONIRS01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Start Dobutamine. If no success switch to Dopamine.
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)
Start Dopamine. If no success switch to Dobutamine.
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 Outcomes

Measure
Cerebral tissue oxygen saturation
time frame: during study medication

Secondary Outcomes

Measure
Cardiac output
time frame: during treatment
Cardiac output
time frame: during study medication

Eligibility Criteria

Male or female participants up to 44 weeks old.

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

Additional Information

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
Principal investigator Manuel B Schmid, Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Ulm.