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

NCT01427686 | Unknown Phase 4

• 1 other identifier: ULMNEONIRS01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cerebral tissue oxygen saturation

  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

  during study medication

Secondary Outcomes (2)

• Cardiac output

  during treatment

• Cardiac output

  during study medication

Study Arms (2)

Dobutamine

ACTIVE COMPARATOR

Start Dobutamine. If no success switch to Dopamine.

Drug: Dobutamine

Dopamine

ACTIVE COMPARATOR

Start Dopamine. If no success switch to Dobutamine.

Drug: Dopamine

Interventions

Dobutamine 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.

Dobutamine

Dopamine 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.

Dopamine

Eligibility Criteria

• Age: Up to 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• fluid refractory arterial hypotension
• newborn infant below 44 weeks postmenstrual age
• parental informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University Medical Center, Ulm University

Ulm, Baden-Wurttemberg, 89075, Germany

Location

MeSH Terms

Conditions

Hypotension

Interventions

Dobutamine; Dopamine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Biogenic Monoamines; Biogenic Amines

Study Officials

• Manuel B Schmid, Dr. med.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DE (1)