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

Sponsor

University of Ulm (Other)

Overall Status

Unknown status

CT.gov ID

NCT01427686

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypotension	Drug: Dobutamine Drug: Dopamine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Jun 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dobutamine Start Dobutamine. If no success switch to Dopamine.	Drug: 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: Dopamine Start Dopamine. If no success switch to Dobutamine.	Drug: 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.

Arm

Intervention/Treatment

Active Comparator: Dobutamine

Start Dobutamine. If no success switch to Dopamine.

Drug: 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: Dopamine

Start Dopamine. If no success switch to Dobutamine.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Cerebral tissue oxygen saturation [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

Secondary Outcome Measures

Cardiac output [during treatment]
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Cardiac output [during study medication]
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 44 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center, Ulm University	Ulm	Baden-Württemberg	Germany	89075

Sponsors and Collaborators

University of Ulm

Investigators

Principal Investigator: Manuel B Schmid, Dr. med., University of Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manuel Schmid, Dr. med., University of Ulm

ClinicalTrials.gov Identifier:

NCT01427686

Other Study ID Numbers:

ULMNEONIRS01

First Posted:

Sep 1, 2011

Last Update Posted:

Apr 6, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Hypotension

Dobutamine

Dopamine

Study Results

No Results Posted as of Apr 6, 2016