HypotensionNCT01318278
Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
A study testing Dopamine and Arginine Vasopressin in people with Hypotension, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Hypotension
- What is being tested?
- Dopamine and Arginine Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 24 hours of age
- Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
- Not initiated on any continuous pressor therapy prior to enrollment
- Intravenous line in place
- Outborn infants meeting eligibility criteria
Who cannot join
- Infants not meeting eligibility criteria
- Infants with life-threatening congenital defects
- Infants with congenital hydrops
- Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
- Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of their lives. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Research is being conducted to try to find the best medication to use in these situations. Dopamine is often used first, but it does not always prove to be effective, and it has several concerning side effects. This study will look at vasopressin, which has fewer side effects, as a first-line medication for low blood pressure in extremely low birth weight infants.
Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in preterm, extremely low birth weight infants who have hypotension within the first 24 hours of life. We will specifically look at its ability to raise blood pressure values, improve clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.
Read the detailed description
Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase. Severe, prolonged hypotension contributes to cellular dysfunction and cell death. Systemic hypotension affects close to half of all ELBW infants and a significant portion of LBW infants. The true definition of hypotension remains to be a question. There is a linear association between birth weight, gestational age, and mean blood pressure but blood pressure can vary significantly in the first day of life. The critical period tends to be the first 24-36 hours of life as blood pressure tends to rise significantly in the first 72 hours of life regardless of gestational age. Preterm infants suffering from hypotension have a higher incidence and increased severity of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and long-term neurodevelopmental sequelae compared to normotensive preterm infants. Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Dopamine is commonly used as first-line therapy, but issues with efficacy and its side effect profile have lessened its favorability over the years. Few studies compare dopamine to other agents as a first -line treatment. This study hopes to contribute to the literature information on vasopressin as a potential first-line agent for treatment of neonatal hypotension in low birth weight infants.
- Conditions
- Hypotension
- Being tested
- Dopamine, Arginine Vasopressin
- Keywords
- Hypotension, Low blood pressure, Neonate, Dopamine, Vasopressin, Extremely Low Birth Weight Infant
- Medical subject headings
- Hypotension, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
Also called Dopamine Hydrochloride
dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy
Arginine VasopressinDrug
Also called Vasopressin, Antidiuretic Hormone (ADH), Pitressin (US brand name), Pressyn;Pressyn AR (Canadian brand names)
vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy
| Study group | Role | What they receive |
|---|---|---|
| Dopamine treatment | Active comparator | Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Receives: Drug: Dopamine |
| Vasopressin treatment | Active comparator | Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Receives: Drug: Arginine Vasopressin |
| Comparison Arm | No intervention | Infants who did not require vasopressor support for hypotension during the first 24 hours of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life
Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
Measured: 24 hours of life
Secondary outcomes (12)
Heart Rate Change From Baseline
Heart rate change from baseline during study drug administration
Measured: 96 hours or until hypotension completely resolved and medications stopped
Acid-base Status
Measured: 96 hours or until hypotension resolved and medication completely stopped
Hyponatremia
Measured: 96 hours or until medication completely stopped
Urine Output
Measured: 96 hours or until hypotension resolved and medication completely stopped
Evidence of Ischemic Changes
Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.
Measured: 96 hours or until medication completely stopped
Necrotizing Enterocolitis
Measured: until hospital discharge, up to 12 weeks
Ventilator Days
Measured: Until hospital discharge, up to 15 months
Presence of Patent Ductus Arteriosus (PDA)
Measured: until hospital discharge, up to 12 weeks
Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound
Measured: Until hospital discharge, up to 15 months
Retinopathy of Prematurity Stage 3 or Higher
All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.
Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages.
Measured: Until hospital discharge, up to 15 months
Presence of Bronchopulmonary Dysplasia (BPD)
Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
Measured: 36 weeks postmenstrual age
All Cause Mortality
Measured: admission to hospital discharge, up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Danielle Rios, Baylor College of Medicine
- Investigators
- Danielle R Rios, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318278
- Sponsor's protocol ID
- H-27661
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2011
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rios DR, Kaiser JR. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study. J Pediatr. 2015 Apr;166(4):850-5. doi: 10.1016/j.jpeds.2014.12.027. Epub 2015 Jan 29.
PubMed 25641242
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT01318278
- Acronym / sponsor ID
- H-27661
- Conditions
- Hypotension
- Keywords
- Hypotension, Low blood pressure, Neonate, Dopamine, Vasopressin, Extremely Low Birth Weight Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Posted 10 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of their lives. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Research is being conducted to try to find the best medication to use in these situations. Dopamine is often used first, but it does not always prove to be effective, and it has several concerning side effects. This study will look at vasopressin, which has fewer side effects, as a first-line medication for low blood pressure in extremely low birth weight infants.
Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in preterm, extremely low birth weight infants who have hypotension within the first 24 hours of life. We will specifically look at its ability to raise blood pressure values, improve clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.
Detailed description
Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase. Severe, prolonged hypotension contributes to cellular dysfunction and cell death. Systemic hypotension affects close to half of all ELBW infants and a significant portion of LBW infants. The true definition of hypotension remains to be a question. There is a linear association between birth weight, gestational age, and mean blood pressure but blood pressure can vary significantly in the first day of life. The critical period tends to be the first 24-36 hours of life as blood pressure tends to rise significantly in the first 72 hours of life regardless of gestational age. Preterm infants suffering from hypotension have a higher incidence and increased severity of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and long-term neurodevelopmental sequelae compared to normotensive preterm infants. Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Dopamine is commonly used as first-line therapy, but issues with efficacy and its side effect profile have lessened its favorability over the years. Few studies compare dopamine to other agents as a first -line treatment. This study hopes to contribute to the literature information on vasopressin as a potential first-line agent for treatment of neonatal hypotension in low birth weight infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dopamine treatment | Active comparator | Drug: DopamineDopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min |
| Vasopressin treatment | Active comparator | Drug: Arginine VasopressinArginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr |
| Comparison Arm | No intervention | –Infants who did not require vasopressor support for hypotension during the first 24 hours of life |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants less than 24 hours of age
- Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
- Not initiated on any continuous pressor therapy prior to enrollment
- Intravenous line in place
- Outborn infants meeting eligibility criteria
Key exclusion criteria (5 listed)
- Infants not meeting eligibility criteria
- Infants with life-threatening congenital defects
- Infants with congenital hydrops
- Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
- Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).
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 |
|---|---|---|
| DopamineAlso: Dopamine Hydrochloridedopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy | Drug | Dopamine treatment |
| Arginine VasopressinAlso: Vasopressin, Antidiuretic Hormone (ADH), Pitressin (US brand name), Pressyn;Pressyn AR (Canadian brand names)vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy | Drug | Vasopressin treatment |
Primary outcome
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life
Time frame: 24 hours of life
Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
12 secondary outcomes
Heart Rate Change From Baseline
Time frame: 96 hours or until hypotension completely resolved and medications stopped
Acid-base Status
Time frame: 96 hours or until hypotension resolved and medication completely stopped
Hyponatremia
Time frame: 96 hours or until medication completely stopped
Urine Output
Time frame: 96 hours or until hypotension resolved and medication completely stopped
Evidence of Ischemic Changes
Time frame: 96 hours or until medication completely stopped
Necrotizing Enterocolitis
Time frame: until hospital discharge, up to 12 weeks
Ventilator Days
Time frame: Until hospital discharge, up to 15 months
Presence of Patent Ductus Arteriosus (PDA)
Time frame: until hospital discharge, up to 12 weeks
Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound
Time frame: Until hospital discharge, up to 15 months
Retinopathy of Prematurity Stage 3 or Higher
Time frame: Until hospital discharge, up to 15 months
Presence of Bronchopulmonary Dysplasia (BPD)
Time frame: 36 weeks postmenstrual age
All Cause Mortality
Time frame: admission to hospital discharge, up to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25641242Rios DR, Kaiser JR. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study. J Pediatr. 2015 Apr;166(4):850-5. doi: 10.1016/j.jpeds.2014.12.027. Epub 2015 Jan 29.
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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.
Danielle R Rios, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dopamine and Arginine Vasopressin in people with Hypotension, run by Baylor College of Medicine at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 20 Feb 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life (time frame: 24 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318278, which also lists 1 linked publication.
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 20 Feb 2019.