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

Arterial Hypotension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arterial Hypotension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DobutamineStart 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.

Drug:DopamineStart 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DobutamineStart Dobutamine. If no success switch to Dopamine.

DopamineStart Dopamine. If no success switch to Dobutamine.

Study Status

Unknown status

Start Date: June 2011

Completed Date: December 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Cerebral tissue oxygen saturation

Secondary Outcome: Cardiac output

Study sponsors, principal investigator, and references

Principal Investigator: Manuel B Schmid, Dr. med.

Lead Sponsor: University of Ulm

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01427686

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