An interventional study of Dopamine and Arginine Vasopressin in Hypotension, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
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.
1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 686 interventional studies indexed under Hypotension.
Browse Hypotension studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 111 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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Exclusion Criteria:
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
Drug: Dopamine
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
Drug: Arginine Vasopressin
Infants who did not require vasopressor support for hypotension during the first 24 hours of life
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
Also known as: Dopamine Hydrochloride
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
Also known as: Vasopressin, Antidiuretic Hormone (ADH), Pitressin (US brand name), Pressyn;Pressyn AR (Canadian brand names), Argipressin
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
Time frame: 24 hours of life
Heart Rate Change From Baseline
Heart rate change from baseline during study drug administration
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
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.
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
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.
Time frame: 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
Time frame: 36 weeks postmenstrual age
All Cause Mortality
Time frame: admission to hospital discharge, up to 15 months
| Milestone | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Started | 10 | 10 | 50 |
| Completed | 10 | 10 | 50 |
| Not completed | 0 | 0 | 0 |
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
| participants | Dopamine Treatment | Vasopressin Treatment |
|---|---|---|
| Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life | 9 | 9 |
Heart rate change from baseline during study drug administration
| beats per minute | Dopamine Treatment | Vasopressin Treatment |
|---|---|---|
| Heart Rate Change From Baseline | 31 ± 19 | 0 ± 10 |
| pH | Dopamine Treatment | Vasopressin Treatment | Comparison Group |
|---|---|---|---|
| Acid-base Status | 7.18 ± .07 | 7.2 ± .07 | 7.25 ± .09 |
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Hyponatremia | 3 | 3 | 11 |
| ml/kg/hr | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Urine Output | 4.4 ± 1.4 | 3.5 ± 1.4 | 3.9 ± 1.4 |
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.
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Evidence of Ischemic Changes | 0 | 0 | 0 |
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Necrotizing Enterocolitis | 0 | 1 | 2 |
| days | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Ventilator Days | 52 (37 to 160) | 45.5 (23.5 to 56) | 17.5 (1 to 38) |
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Presence of Patent Ductus Arteriosus (PDA) | 5 | 6 | 34 |
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound | 3 | 3 | 6 |
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.
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Retinopathy of Prematurity Stage 3 or Higher | 3 | 2 | 4 |
Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| Presence of Bronchopulmonary Dysplasia (BPD) | 8 | 4 | 31 |
| participants | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| All Cause Mortality | 2 | 4 | 10 |
Collected over Participants were followed for the duration of hospital stay, up to 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dopamine Treatment | 2/10 (20%) | 8/10 (80%) | 3/10 (30%) |
| Vasopressin Treatment | 4/10 (40%) | 7/10 (70%) | 4/10 (40%) |
| Comparison Arm | 10/50 (20%) | 22/50 (44%) | 11/50 (22%) |
| Event | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| SepsisInfections and infestations | 4/10 | 5/10 | 11/50 |
| Bowel PerforationGastrointestinal disorders | 3/10 | 2/10 | 4/50 |
| Necrotizing EnterocolitisGastrointestinal disorders | 1/10 | 0/10 | 7/50 |
| Event | Dopamine Treatment | Vasopressin Treatment | Comparison Arm |
|---|---|---|---|
| HyponatremiaRenal and urinary disorders | 3/10 | 4/10 | 11/50 |
| Age, Continuous(weeks) | Dopamine Treatment | Vasopressin Treatment | Comparison Arm | Total |
|---|---|---|---|---|
| Mean | 25.1 ± 1 | 25.7 ± 2 | 25.6 ± 1 | 25.6 ± 1.4 |
| Sex: Female, Male(Participants) | Dopamine Treatment | Vasopressin Treatment | Comparison Arm | Total |
|---|---|---|---|---|
| Female | 5 | 4 | 28 | 37 |
| Male | 5 | 6 | 22 | 33 |
The record gives a start of Mar 2011, a primary completion of Jan 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2015, 2 years 2 months after primary completion.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dopamine · Arginine Vasopressin