Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318278
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : March 10, 2015
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Danielle Rios, Baylor College of Medicine

Brief 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 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.


Condition or disease Intervention/treatment Phase
Hypotension Drug: Dopamine Drug: Arginine Vasopressin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
Study Start Date : March 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dopamine treatment
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
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
Other Name: Dopamine Hydrochloride

Active Comparator: Vasopressin treatment
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
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
Other Names:
  • Vasopressin
  • Antidiuretic Hormone (ADH)
  • Pitressin (US brand name)
  • Pressyn;Pressyn AR (Canadian brand names)
  • Argipressin

No Intervention: Comparison Arm
Infants who did not require vasopressor support for hypotension during the first 24 hours of life



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Heart Rate Change From Baseline [ Time Frame: 96 hours or until hypotension completely resolved and medications stopped ]
    Heart rate change from baseline during study drug administration

  2. Acid-base Status [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  3. Hyponatremia [ Time Frame: 96 hours or until medication completely stopped ]
  4. Urine Output [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  5. Evidence of Ischemic Changes [ Time Frame: 96 hours or until medication completely stopped ]
    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.

  6. Necrotizing Enterocolitis [ Time Frame: until hospital discharge, up to 12 weeks ]
  7. Ventilator Days [ Time Frame: Until hospital discharge, up to 15 months ]
  8. Presence of Patent Ductus Arteriosus (PDA) [ Time Frame: until hospital discharge, up to 12 weeks ]
  9. Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound [ Time Frame: Until hospital discharge, up to 15 months ]
  10. Retinopathy of Prematurity Stage 3 or Higher [ Time Frame: Until hospital discharge, up to 15 months ]

    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.


  11. Presence of Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks postmenstrual age ]
    Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD

  12. All Cause Mortality [ Time Frame: admission to hospital discharge, up to 15 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318278


Locations
Layout table for location information
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Thrasher Research Fund
Investigators
Layout table for investigator information
Principal Investigator: Danielle R Rios, M.D. Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Danielle Rios, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01318278    
Other Study ID Numbers: H-27661
First Posted: March 18, 2011    Key Record Dates
Results First Posted: March 10, 2015
Last Update Posted: February 20, 2019
Last Verified: January 2019
Keywords provided by Danielle Rios, Baylor College of Medicine:
Hypotension
Low blood pressure
Neonate
Dopamine
Vasopressin
Extremely Low Birth Weight Infant
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Birth Weight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Dopamine
Vasopressins
Arginine Vasopressin
Physiological Effects of Drugs
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents