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

NCT ID: NCT01427686

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Arterial Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dobutamine

Start Dobutamine. If no success switch to Dopamine.

Group Type: ACTIVE_COMPARATOR

Dobutamine

Intervention Type: DRUG

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.

Dopamine

Start Dopamine. If no success switch to Dobutamine.

Group Type: ACTIVE_COMPARATOR

Dopamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 44 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Manuel Schmid

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel B Schmid, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

University Medical Center, Ulm University

Ulm, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

ULMNEONIRS01

Identifier Type: -

Identifier Source: org_study_id