Arterial HypotensionPhase 4NCT01427686
Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates
A Phase 4 study testing Dobutamine and Dopamine in people with Arterial Hypotension, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 44 weeks
- Conditions the study is for
- Arterial Hypotension
- What is being tested?
- Dobutamine and Dopamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- fluid refractory arterial hypotension
- newborn infant below 44 weeks postmenstrual age
- parental informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center, Ulm University
Ulm, Baden-Wurttemberg, 89075
About this study
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
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
- Being tested
- Dobutamine, Dopamine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
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.
DopamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine | Active comparator | Start Dobutamine. If no success switch to Dopamine. Receives: Drug: Dobutamine |
| Dopamine | Active comparator | Start Dopamine. If no success switch to Dobutamine. Receives: Drug: Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during study medication
Secondary outcomes (2)
Cardiac output
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Measured: during treatment
Cardiac output
Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry
Measured: during study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Schmid, University of Ulm
- Investigators
- Manuel B Schmid, Dr. med., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427686
- Sponsor's protocol ID
- ULMNEONIRS01
- Status last verified
- Apr 2016
- First submitted
- 31 Aug 2011
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427686
- Acronym / sponsor ID
- ULMNEONIRS01
- Conditions
- Arterial Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dobutamine | Active comparator | Drug: DobutamineStart Dobutamine. If no success switch to Dopamine. |
| Dopamine | Active comparator | Drug: DopamineStart Dopamine. If no success switch to Dobutamine. |
Who may qualify
- Ages
- Up to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- fluid refractory arterial hypotension
- newborn infant below 44 weeks postmenstrual age
- parental informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dobutamine |
| 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. | Drug | Dopamine |
Primary outcome
Cerebral tissue oxygen saturation
Time frame: 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
2 secondary outcomes
Cardiac output
Time frame: during treatment
Cardiac output
Time frame: during study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel B Schmid, Dr. med. principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dobutamine and Dopamine in people with Arterial Hypotension, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral tissue oxygen saturation (time frame: during study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.